Biosimilars. Their regulatory status and their use
|
|
- Wilfrid French
- 6 years ago
- Views:
Transcription
1 Biosimilars Their regulatory status and their use Bruno Flamion, MD, PhD Professor of Physiology & Pharmacology, University of Namur, Belgium Past Chair of the European Medicines Agency (EMA) Scientific Advice Group Past Chair of the Committee for Reimbursement of Medicines in Belgium (CTG/CRM)
2 History of biological products (or biologics ) 1890 serum therapy (von Behring) 1921 discovery of insulin (Banting & Best) 1983 Humulin, first recombinant drug (Genentech/Eli Lilly) 1986 muromomab, first (murine) monoclonal Ab 1989 epoietin alpha (Epogen ), first therapeutic glycoprotein (Amgen) 1994 abciximab, first chimeric monoclonal Ab 1996 daclizumab, first humanized monoclonal Ab 1997 rituximab (Mabthera ); 1998 trastuzumab (Herceptin ); 1999 infliximab (Remicade ) 2002 adalimumab (Humira ), first human monoclonal Ab 2004 bevacizumab (Avastin ), cetuximab (Erbitux ) 2
3
4 Definition of a biosimilar 1. = a copy of a biologic (which cannot be exactly the same for biological reasons) but not a simple copy ( intended copy ). 2. The biosimilar copy must have successfully completed a comparability exercise vs the originator ( the reference product ). 3. During that exercise the biosimilar must pass a number of qualifications, assays, non-clinical tests, and also (at least in the EU) clinical tests. 4. This exercise must meet strict regulatory requirements, for instance those set up by the European Medicines Agency (EMA) or, more recently, the FDA 5. The goal is to ensure that using the biosimilar instead of the reference product entails a very low (negligible) likelihood of clinically significant difference. 4
5 Regulations vary across the world EMA-like regulation «Simple copy» or generic regulation No regulation European Union (EMA) since 2005 Mexico China * USA (FDA) since 2012 Peru Russia WHO since 2009 Canada Australia Japan South Korea, Taiwan South Africa, Jordan Turkey, Brazil (new) Chile India * Out of 382 biologics on the market in China, 361 are simple copies 5
6 Economic push: EPO price competition in Germany 6
7 Economic push: use of filgrastim in Europe 7
8 Variable uptake of biosimilar G-CSF in Europe
9 How to make a similar biological product? Biologics have a complex manufacturing process that makes them difficult to copy; the end product is not to exactly the same as the originator Cloning into DNA vector Coding gene mutation Transfer into host cell expression Different purification and formulation protocols Dörner T, et al. Ann Rheum Dis. 2013;72(3): Ahmed I. Clinical Therapeutics 2012; 34(2): Different cell culture processes
10 The size matters A political decision was made in 2004 to allow official copies of existing biological products based on a reduced dossier in parallel with the generic concept taking advantage of experience with the comparability of biotech products after a change in manufacturing process The goal was (is) purely pharmaco-economical There is no official definition of a biosimilar in the EU From Joerg Windisch, CSO Sandoz 10
11 but also the intrinsic heterogeneity (e.g. glycoforms) Biologicals are micro-heterogeneous mixtures of several isoforms, each of which may differ in terms of potency, half-life and immunogenicity Rudd, P. M., et al. (1997) The glycosylation of the complement regulatory protein, human erythrocytes CD59. J. Biol. Chem. 272:
12 Example of biological product complexity pyro-e D O O G D D O G O pyro-e D Pyro-Glu (2) Deamidation (3 x 2) Methionine oxidation (2 x 2) D D Glycation (2 x 2) G G High mannose, G0, G1, G2 (5) K K (9600) potential variants Sialylation (5) C-term Lys (2) 2 x 6 x 4 x 4 x 5 x 5 x 2 = 9600 Modified from: Koszlowski, S. & Swann, P. (2006) Adv. Drug Delivery Revs. 58,
13 EMA requirements for biosimilar approvals *** *** Including receptor binding assays (affinity, reversibility), epitope analysis (for a MAb), bioassays )
14 The comparability exercise (ICH, 2004) 14
15 Comparability Exercise for existing products Number of manufacturing changes approved for mabs/-cepts in rheumatology The latest versions of Remicade are «biosimilars» of the previous versions From Schneider CK et al., Ann Rheum Dis 2013; 72:315 Physicochemical characteristics of subsequent products do not have to be identical but «highly similar» (they may be slightly improved) 15
16 Comparability Exercise vs Biosimilarity Comparability (change in manufacturing process) Thorough internal knowledge by manufacturer Extensive analytical data Low need for clinical data Biosimilarity No internal knowledge Extensive analytical data High need for clinical data Noninferiority tests Therapeutic equivalence If the comparison fails at any stage, the products cannot be declared biosimilar 16
17 EMA guidelines for biosimilar development 17
18 Biosimilars at the European Medicines Agency (1) Omnitrope (somatropin) Sandoz (Novartis) Authorized 2 Valtropin (somatropin) [yeast] Biopartners Authorized 3 Alpheon (interferon alfa) BioPartners Negative 4 Binocrit (epoetin alfa) Sandoz (Novartis) Authorized 5 Epoetin alfa Hexal (epoetin alfa) Hexal (Novartis) Authorized 6 Abseamed (epoetin alfa) Medice Authorized 7 Silapo (epoetin zeta) Stada Authorized 8 Retacrit (epoetin zeta) Hospira Authorized 9 Insulin Marvel Short (human insulin) Marvel Life Sci Negative 10 Insulin Marvel Intermediate (human insulin) Marvel Life Sci Negative 11 Insulin Marvel Long (human insulin) Marvel Life Sci Negative 12 Filgrastim Ratiopharm (filgrastim) Ratiopharm Authorized 13 Biograstim (filgrastim) CT Arzneimittel Authorized 14 Tevagrastim (filgrastim) Teva Authorized 15 Zarzio (filgrastim) Sandoz (Novartis) Authorized 16 Filgrastim Hexal Hexal (Novartis) Authorized 17 Biferonex (interferon beta-1a) BioPartners Negative 18 Nivestim (filgrastim) Hospira Authorized 1 2-withdrawn 3 4 These 3 products are identical!! 5 6 7
19 Biosimilars at the European Medicines Agency (2) Identical products MAb In all indications!! Remsima (infliximab) Celltrion Authorized 20 Inflectra (infliximab) Hospira Authorized 8 ** 21 Ovaleap (follitropin alpha) Teva Authorized 22 Gastrofil (filgrastim) Apotex Authorized Bemfola (follitropin alpha) Finox Biotech AG Authorized Abasaglar (insulin glargine) Lilly-Boehringer Authorized 12 NB. At FDA: Basaglar (not a biosimilar 505(b) procedure Biosimilars under evaluation 1 insulin at EMA NB. Celltrion s trastuzumab approved in S. Korea (January 2014) 7 Jan 2014: FDA Oncology Advisory Committee supported Zarxio as biosimilar ** Marketed in Norway, Portugal, Ireland, Finland, Eastern Europe; pending patent issues in other EU States FDA-approved
20 FDA Guidance (2012) and issues Q/S/E stepwise approach (like EU); decision based on the totality of evidence The extent of clinical study required depends on remaining uncertainty after in vitro and animal testing (some biosimilars could be approved without a need for clinical trials) FDA is obliged to rule also on the interchangeability of each biosimilar (yes or no): product expected to produce the same clinical outcome as the reference product in any given patient The biosimilar company has to reveal the details of its manufacturing methods to the originator Will FDA use the same INN? NB. FDA accepted the Remsima biosimilar application in August
21 Why is there (still) a debate on biosimilars?
22 The biosimilar concept is purely pharmacoeconomic Without a reduction in regulatory requirements, this concept is not tenable How can regulatory requirements be reduced without undue risks (unacceptable loss of efficacy, or unexpected immunogenicity)? 22
23 Methods agreed by regulators to ensure efficacy and safety of biosimilars with less patients than originator 1. At least one accurate PK study (if possible, PK/PD data) 2. Less patients but enough statistical power to detect differences if they exist: more homogeneous population * in principle, the most sensitive endpoints * reasonable equivalence margins ( leads to some additional uncertainty) 3. Extrapolation of indications if the mechanism of action, safety and immunogenicity are expected to be similar in these indications 4. Reinforced Risk Management Plan (RMP) * For anti-tnf, RA is a sensitive population (perhaps more sensitive than IBD or psoriasis) * In oncology, it is preferable to use early stage cancer patients and a «response rate» endpoint rather than survival rates 23
24 Response Rate, % Results of CT-P13 (infliximab) Phase III equivalence trial N= 606. Primary efficacy endpoint: ACR20 response at week Treatment difference = 2% (95% CI: 6%, 10%) Treatment difference = 4% (95% CI: -4%, 12%) 184/ / / /251 ITT Population PP Population CT-P13 INX Safety: Treatment-emergent adverse events were seen in 35.2% of patients treated with CT-P13 and 35.9% of patients treated with INX Immunogenicity: Equivalent levels of anti-infliximab antibodies were detected in both treatment arms at week 14 and week 30 Yoo DH, et al. Ann Rheum Dis. 2013;72(10):
25 Evolution of Remicade (EU): Efficacy RA: joint damage Fistulizing CD maintenance Moderate/ Severe Psoriasis Crohn s Disease Ankylosing Spondylitis Psoriatic Arthritis RA: signs and symptoms RA: physical function Luminal CD maintenance Early RA Ulcerative Colitis Basis for extrapolation of indications for Remsima /Inflectra, together with PK data in AS + Post-approval commitment for a Ph III trial in Crohn s disease
26 Biosimilar MAbs in oncology The clinical issues are not different from other biosimilars but extrapolation may be technically more difficult Very complex production Very complex mechanism of action Complex (oncology) indications 26
27 Increased immunogenicity of biosimilars? EMA/CHMP. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues.
28 Immunogenicity & traceability 1. Immunogenicity in humans cannot be predicted from animal data absolute need for comparative clinical trials including tests for neutralizing Abs and PK/PD data 2. How long? Usually 1 year pre-licensing if chronic use is intended; the post-marketing RMP is crucial thereafter 3. Adequate traceability is mandatory. The recommendation is to identify the product (in case of, e.g., hypersensitivity) by INN + brand name + manufacturer + batch number (+ country of origin) NB. Some complain that the SmPC of the biosimilar is identical to that of the originator (except a simple mention in 5.1: «X is a biosimilar detailed information available on website of EMA».) 28
29 Interchangeability 1. Can a patient be switched from an originator to a biosimilar during (chronic) treatment? and vice-versa 2. Studies designed to demonstrate that switching (back and forth) does not entail any additional risk would be long, costly and probably unreasonable (cf. ongoing issue at FDA) 29
30 Recent initiative towards interchangeability NOR-SWITCH study 800 patients started recruiting in November 2014
31 Interchangeability 1. Can a patient be switched from an originator to a biosimilar during (chronic) treatment? and vice-versa 2. Studies designed to demonstrate that switching (back and forth) does not entail any additional risk would be long, costly and probably unreasonable (cf. ongoing issue at FDA) 3. In Europe, demonstrated biosimilarity would imply interchangeability but the decision is up to each Member State. 4. In Belgium, FAMHP excludes biologics from INN prescription and forbids automatic substitution of biologics by pharmacists 31
32 Some Take-Home Messages
33 Take-home messages (1) 1. The biosimilarity concept means a low likelihood of clinically significant differences 2. According to (EU, FDA ) regulators, a product can be called biosimilar only if it has successfully gone through the stepwise (Q/S/E) comparability exercise (i.e., strong regulatory oversight) and is thus considered of high quality, safe, and efficient
34 Take-home messages (2) 3. The focus of the clinical part of the biosimilar exercise is on PK/PD and the use of sensitive populations and endpoints to detect any potential difference 4. Extrapolation of indications is key to the biosimilar concept but needs to be justified in all cases and explained to clinicians!
35 Take-home messages (3) 5. Detection of immunogenicity and a good Risk Management Plan are key elements of safety so far there has been no safety issue with any biosimilar product 6. Traceability should be ensured by prescribing under brand names and keeping good records 7. Interchangeability is a national (or local) issue in most of Europe, automatic substitution by pharmacists is not allowed involving the prescriber is preferable
36 Take-home messages (4) 8.Clinicians, supported by national and local (hospital) decision makers, could give away some prescription habits in favour of lower prices 9.Infliximab biosimilars, impacting on well-defined medical specialties (rheumatologists, gastroenterologists, dermatologists) and high cost situations, will be a good test
37 Thank You!!
How are biosimilars assessed and approved?
How are biosimilars assessed and approved? Bruno Flamion, MD, PhD Professor of Physiology & Pharmacology, University of Namur, Belgium Past Chair of the European Medicines Agency (EMA) Scientific Advice
More informationNaming, tracing, switching and other safety issues after 10 years learning
Naming, tracing, switching and other safety issues after 10 years learning Prof. Dr. Irene Krämer, Department of Pharmacy Johannes Gutenberg-University Medical Center, Mainz (Germany) Disclosures Speaker
More informationBiomanufacturing Capacity for Biosimilars: Is there enough?
Biomanufacturing Capacity for Biosimilars: Is there enough? Cambridge Healthtech Institute s Third Annual BIOAnalytical Summit 2012 Mar 19-22 Baltimore, MD BioProcess Technology Consultants www.bptc.com
More informationACG Public Forum. Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD. Monday, 12:45 pm 2:15 pm
ACG Public Forum Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD Monday, 12:45 pm 2:15 pm ACG 2017: FDA-EMA workshop on biosimilars Joachim Musaus EMA Product Lead Gastroenterology Human
More informationBiosimilars, Regulatory Framework and Outcome So Far
1 Biosimilars, Regulatory Framework and Outcome So Far Inger Mollerup Vice President Regulatory Affairs, Novo Nordisk Sep 24/09/2009 28 2009 1 Disclaimer The views and opinions expressed in the following
More informationGlobal Demand and Utilization of Mammalian Cell Culture Manufacturing Capacity
Global Demand and Utilization of Mammalian Cell Culture Manufacturing Capacity Howard L. Levine, Ph.D. Eighth Annual BioProcess International Europe 2012 Apr 18-19 Prague, Czech Republic BioProcess Technology
More informationBiosimilars Market Update
Biosimilars Market Update Panel: Matthew Brougham Consultant Economist, Brougham Consulting Inc Mark Jackson Consultant Pharmacist, TELUS Health Dr. Ed Keystone Professor of Medicine, University of Toronto
More informationExpectation for the future and the role of the JP
JP 130 th Anniversary Symposium (15 September, 2016) Expectation for the future and the role of the JP From Academia s perspectives Toru KAWANISHI, PhD Director-General National Institute of Health Sciences
More informationBiosimilars Scientific Challenges and Implications
Biosimilars Scientific Challenges and Implications Professor Paul Declerck Laboratory for Therapeutic and Diagnostic Antibodies paul.declerck@pharm.kuleuven.be Biological medicinal product A well-defined
More informationWhat next? Manufacture the biosimilar product
What next? Manufacture the biosimilar product Design manufacturing process to match QTPP Full quality dossier required. Use state of the art technologies In accordance with relevant ICH and CHMP guidelines
More informationWhat Is a Biosimilar?
Learning Objectives Compare and contrast biosimilars to their reference product and generic therapies in terms of structure, manufacturing, regulatory pathway, and clinical properties Evaluate evolving
More informationSimilar biological medicinal product
SSPT, Tunis 13 November 2009 K. HO, Biological department - Biological medicinal product K. HO, Biological department Biological medicinal product Spectrum of complexity Spectrum of complexity Aspirin
More informationPharmacovigilance for Biosimilars
Pharmacovigilance for Biosimilars Dr. Niraj Chhaya Risk Management, Global Pharmacovigilance Boehringer Ingelheim GmbH 5th Annual Pharmacovigilance Forum, GLC Europe 03 March 2017 Berlin, Germany Disclaimer
More informationAn update on development strategies of recently approved biosimilars in Europe. Johanna Mielke
An update on development strategies of recently approved biosimilars in Europe Johanna Mielke Acknowledgement & disclaimer This project was supported by the Swiss State Secretariat for Education, Research
More informationBiosimilar Monoclonal- a reality
Biosimilar Monoclonal- a reality 2 nd MENA Regulatory Conference on Bioequivalence, Biowaivers, BIOANALYSIS, DISSOLUTION AND BIOSIMILARS Jordan DATE September 15-17, 2015 PRESENTED BY Rodeina Challand
More informationWhat is a biosimilar and how does sound biosimilar use look like?
Vs14f17 LBP Opleidingsinstituut voor Care & Cure: Biosimilars in the Market; what does it mean for us? Rotterdam, June 18, 2014. What is a biosimilar and how does sound biosimilar use look like? Arnold
More informationOvercoming Challenges in the Emerging Biosimilar Landscape
Overcoming Challenges in the Emerging Biosimilar Landscape Steven R. Feldman, M.D., Ph.D. Wake Forest University School of Medicine Winston Salem, North Carolina, USA Objectives Identify the safety and
More informationEffect of Naming on Competition and Innovation. Mark McCamish, MD, PhD Global Head Biopharmaceutical Development Washington, DC 10 December 2013
Effect of Naming on Competition and Innovation Mark McCamish, MD, PhD Global Head Biopharmaceutical Development Washington, DC 10 December 2013 1 FTC Biosimilars Workshop on Naming Proposals and Impact
More informationLondon Medicines Evaluation Network Review
London Medicines Evaluation Network Review Answers to commonly asked questions about biosimilar versions of infliximab February 2015 (revised April 2015) Authored by Nicola Hooker (Nicola.Hooker@gstt.nhs.uk)
More informationThe importance of interchangeability in the procurement of medications: Biosimilar case
The importance of interchangeability in the procurement of medications: Biosimilar case ALIMS Congres, Kragujevac, November 6, 2015 Prof. Borut Štrukelj, PhD Brief CV Current position: professor, Pharmaceutical
More informationbiosimilar medicines better access. better health. handbook medicines
biosimilar medicines better access. better health. biosimilar medicines handbook 3 rd edition - 2016 biosimilar medicines better access. better health. biosimilar medicines handbook ABOUT THE BIOSIMILAR
More informationBiosimilars today and tomorrow
Biosimilars today and tomorrow Dr. Jörg Windisch, Head Global Technical Development PMCA Impuls Vienna, April 23, 2012 a Novartis company Patient access is at risk because biosimilars are expensive...
More information: Regulation of biosimilars and success factors for uptake in clinical practice. Steinar Madsen, MD, FACP(Hon) Medical director
2018-02-08: Regulation of biosimilars and success factors for uptake in clinical practice Steinar Madsen, MD, FACP(Hon) Medical director steinar.madsen@legemiddelverket.no Drug costs in Norway Billion
More informationBiosimilars 2016 Balancing Fast Uptake with Industry Sustainability. Dan Ionescu Head of Pricing and Market Access Sandoz Biopharmaceuticals
Biosimilars 2016 Balancing Fast Uptake with Industry Sustainability Dan Ionescu Head of Pricing and Market Access Sandoz Biopharmaceuticals 10 years on, biosimilars have had a strong impact on global healthcare
More informationBiosimilars today or tomorrow?
Oxford Inflammatory Bowel Disease MasterClass Biosimilars today or tomorrow? Dr Vipul Jairath Bsc DPhil MRCP NIHR Clinical Lecturer Translational Gastroenterology Unit University of Oxford John Radcliffe
More informationProfessor Ahmed H Al-jedai, PharmD, MBA, BCPS, FCCP, FAST, Saudi Arabia
GaBI Scientific Meetings First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars 20 November 2017, Holiday Inn Izdihar Riyadh, Saudi Arabia Professor
More informationThe Regulatory and Licensing Process. Dr Anne Cook, Biologicals Quality Assessor, MHRA
The Regulatory and Licensing Process Dr Anne Cook, Biologicals Quality Assessor, MHRA Outline of presentation Licensing Division at MHRA Development/licensing of originator biological medicines Basis of
More informationBiosimilar medicines: practical EU experience and perspectives. 12 Sept 2017 Adrian van den Hoven, Director General, Medicines for Europe
Biosimilar medicines: practical EU experience and perspectives 12 Sept 2017 Adrian van den Hoven, Director General, Medicines for Europe Medicines For Europe VISION Medicines for Europe Vision 2020 Our
More informationEUROPEAN GENERIC MEDICINES ASSOCIATION
biosimilars biosimilars contents Introduction... 6 What this Handbook Covers Whom this Handbook is for Executive Summary... 8 The Importance of Biosimilar Medicines... 11 For Patients For Clinicians For
More informationBiosimilar regulation from a clinical point of view
Biosimilar regulation from a clinical point of view an update on immunogenicity and interchangeability LIS-TNFBio seminar 2018 Scandic Nidelven Hotel Trondheim 20.-21. mars Senior Advisor Project leader
More informationMedicines Agency EMA & Biosimilar update: Trends from marketing authorisation applications, scientific advice procedures and policies
EMA & Biosimilar update: Trends from marketing authorisation applications, scientific advice procedures and policies Presented by: Peter Richardson Head of Quality Office Specialised Scientific Disciplines
More informationImplications for Preclinical and Clinical Programs. Novartis Pharmaceuticals Oncology Business Unit June 2, 2011
EU Biosimilarityi il it Guidance Implications for Preclinical and Clinical Programs Shefali Kakar Novartis Pharmaceuticals Oncology Business Unit June 2, 2011 Biologics are more complex than small molecules
More informationAn Update on Biosimilars and Biosimilar Litigation in the US
An Update on Biosimilars and Biosimilar Litigation in the US Paul A. Calvo, Ph.D. 1 February 2016 2 nd Biologics and Biosimilars Congress - Berlin Years of Nothing and Now 2 Biosimilar approvals in Europe*
More informationBiosimilars in Clinical Practice: Formulary, interchange and substitution considerations (a European perspective)
Soul, September 14, 2017 Biosimilars in Clinical Practice: Formulary, interchange and substitution considerations (a European perspective) Vs17i13 Arnold G. Vulto PharmD PhD FCP Professor of Hospital Pharmacy
More informationBiosimilars Scientific and Regulatory Considerations
Biosimilars Scientific and Regulatory Considerations Gustavo Grampp Regulatory Policy Director, Amgen Presented at Maryland Pharmacists Association meeting January 31, 2016 Program objectives 1. Review
More informationBIOSIMILARS OF PROTEIN BASED DRUGS: CURRENT STATUS AND FUTURE DIRECTIONS
BIOSIMILARS OF PROTEIN BASED DRUGS: CURRENT STATUS AND FUTURE DIRECTIONS George Dranitsaris B.Pharm. PhD Consultant in Health Economics and Biostatistics What is a Biosimilar? Protein based drugs are made
More informationClinical Evaluation and Interchangeability of Biotech Products and Biosimilars (a Clinical Pharmacists View)
Athens, May 25, 2018 Clinical Evaluation and Interchangeability of Biotech Products and Biosimilars (a Clinical Pharmacists View) Vs18e28 Arnold G. Vulto PharmD PhD FCP Professor of Hospital Pharmacy &
More informationThijs J Giezen, PharmD, MSc, PhD The Netherlands
Thijs J Giezen, PharmD, MSc, PhD The Netherlands Hospital Pharmacist, Foundation Pharmacy for Hospitals in Haarlem, The Netherlands Member of the Biosimilar Medicinal Product Working Party of European
More informationBiosimilars 101: How similar are they?
Biosimilars 101: How similar are they? Matthew Marston, Pharm.D., BCPS, BCOP Senior Manager of Clinical Pharmacy Services Miller Drug, LLC Outline Describe the approval and manufacturing process of biologics
More informationWhat is the Role of HTA for Biosimilars? Jorge Mestre-Ferrandiz and Adrian Towse, Office of Health Economics
April 2014 Briefing 54 What is the Role of HTA for Biosimilars? Jorge Mestre-Ferrandiz and Adrian Towse, Office of Health Economics This Briefing contains a summary of the main points and conclusions from
More informationof biosimilar monoclonal antibodies Considerations on some Regulatory and Clinical Topics Dr. Thomas Schreitmueller, Regulatory Policy, Biologics
Regulating the development and approval of biosimilar monoclonal antibodies Considerations on some Regulatory and Clinical Topics Dr. Thomas Schreitmueller, Regulatory Policy, Biologics Biological product
More informationThis presentation was developed by the Government & Industry Affairs Committee of the Crohn s & Colitis Foundation of America
This presentation was developed by the Government & Industry Affairs Committee of the Crohn s & Colitis Foundation of America The development of this presentation was supported in 2016 by a sponsorship
More informationQuality, Safety and Efficacy of Follow-on Biologics Teruhide YAMAGUCHI
Quality, Safety and Efficacy of Follow-on Biologics Teruhide YAMAGUCHI Division of Biological Chemistry and Biologicals National Institute of Health Sciences Quality, Safety and Efficacy of Follow-on Biologics
More informationImmunogenicity: Impact on the Design of Clinical Trials for Biosimilars
Immunogenicity: Impact on the Design of Clinical Trials for Biosimilars Alexander Berghout, M.D., Ph.D. Head Global Clinical Research and Development Sandoz Biopharmaceuticals BMWP/BWP Workshop on Immunogenicity
More informationreview article Biosimilar insulins: a European perspective
Biosimilar insulins: a European perspective J. H. DeVries 1,S.C.L.Gough 2, J. Kiljanski 3 & L. Heinemann 4 1 Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands 2 Oxford Centre for Diabetes,
More informationBiologicals and biosimilars in the wind - what is new?
Biologicals and biosimilars in the wind - what is new? An update of biologics & biosimilar regulation SciLifeLab Drug Discovery and Development Platform Workshop 12th of June 2017 Venke Skibeli, Senior
More informationWinning the Race on Biosimilars
BioPharma Product Testing Winning the Race on Biosimilars By Dr Jon S Kauffman, Dr Weihong Wang and Dr Frederic Girard at Eurofins European Biopharmaceutical Review ISSUE 76 JULY 2016 UNFOGGING THE FUTURE
More informationBiosimilar Development Clinical Investigator Considerations
Biosimilar Development Clinical Investigator Considerations June 2011 www.ppdi.com Biosimilar products are not new in the pharmaceutical industry. However, the pending expiration of numerous therapeutic
More informationRegulation of Biosimilars in Canada
Regulation of Biosimilars in Canada Session 2: Global Regulatory Trends of Biosimilars GBC 2018 June 28, 2018 Stephanie Hardy Office of Policy and International Collaboration Biologics and Genetic Therapies
More informationThe Changing Landscape of Mammalian Cell Culture Manufacturing Capacity
The Changing Landscape of Mammalian Cell Culture Manufacturing Capacity Howard L. Levine, Ph.D. Eighth Annual bioprocessuk Conference Nov 30-Dec 1 2011 Glasgow, Scotland BioProcess Technology Consultants
More informationHow much evidence is provided prior to approval? An updated systematic review of biosimilar applications in Europe
How much evidence is provided prior to approval? An updated systematic review of biosimilar applications in Europe Johanna Mielke (johanna.mielke@novartis.com), Byron Jones, Franz Koenig, Bernd Jilma This
More informationThe Future has Arrived: Biosimilars
The Future has Arrived: Biosimilars Overview of the Regulatory Framework and FDA s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US Sue Lim, M.D., Director
More informationACG Public Forum. Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD. Monday, 12:45 pm 2:15 pm
ACG Public Forum Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD Monday, 12:45 pm 2:15 pm Biosimilars for IBD: What the Gastroenterologist Needs to Know Tara Altepeter, MD Clinical Team
More informationInternational Journal of Research in Pharmacy and Science
Review Article Available online www.ijrpsonline.com ISSN: 2249 3522 International Journal of Research in Pharmacy and Science The Opportunities and Challenges Involved in Registration of Similar Biotherapeutic
More informationOptimizing the Development of Biosimilars Using PK/PD: Recent Scientific and Regulatory Advances
Optimizing the Development of Biosimilars Using PK/PD: Recent Scientific and Regulatory Advances Jian Wang, MD, PhD Chief, Clinical Evaluation Division Biologics and Genetic Therapies Directorate Health
More informationThe Future has Arrived: Biosimilars
The Future has Arrived: Biosimilars Overview of the Regulatory Framework and FDA s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US Sue Lim, M.D., Director
More informationWhy even have this talk? Disclosures. What will biosimilars mean for us? Annual Revenue Due to Adalimumab. Biosimilars 2017: What We Need to Know
Biosimilars 2017: What We Need to Know Why even have this talk? Miguel Regueiro, M.D. Professor of Medicine IBD Clinical Medical Director Senior Medical Lead, Specialty Medical Homes University of Pittsburgh
More informationProfessor Andrea Laslop, MD, Austria
GaBI Scientific Meetings ROUNDTABLE ON BIOSIMILARS with participation by European Regulators and Medical Societies 12 January 2016, Sheraton Brussels Airport Hotel, Belgium Professor Andrea Laslop, MD,
More informationACG Public Forum. Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD. Monday, 12:45 pm 2:15 pm
ACG Public Forum Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD Monday, 12:45 pm 2:15 pm Overview of the Regulatory Pathway and FDA s Guidance for the Development and Approval of Biosimilar
More informationBIOSIMILARS: ON THE REALM OF REALITY DETERMINANTS OF SUCCESS
1 Originally presented at the 2013 AAPS National Biotechnology Conference - BIOTEC Open Forum Update (see slide #2) 7/14/2013 BIOSIMILARS: ON THE REALM OF REALITY DETERMINANTS OF SUCCESS Ajaz Insight 2
More informationThe EU Market Environment for Biosimilar Medicines
1 The EU Market Environment for Biosimilar Medicines 12 th Annual IGPA Conference Sep 30-Oct 2, 2009 Montreal Suzette Kox Senior Director Scientific Affairs European Generic medicines Association 2 Outlines
More informationProfessor Tore Kristian Kvien, MD, PhD, Norway
GaBI Scientific Meetings 10 October 2018, Le Meridien Dubai, United Arab Emirates 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars
More informationBiosimilar Product Structural Characterization - Strategies for Comparability Analysis.
Biosimilar Product Structural Characterization - Strategies for Comparability Analysis. Dr Fiona M Greer Global Director, BioPharma Services Development, SGS M-Scan CASSS 8th Symposium on the Practical
More informationBiosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments
Biosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments Ministry of Food and Drug Safety Jeewon Joung Outline I. Korean Regulatory Framework for Biosimilar
More informationTHE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS
THE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS What all developers need to know Alicia Baker Director, Global Regulatory Affairs Strategy, Covance John Carlsen, MHA Vice President,
More informationFormulary Considerations for Biosimilars in healthcare systems
Formulary Considerations for Biosimilars in healthcare systems Ahmed Aljedai, Pharm.D., M.B.A, BCPS, FCCP, FAST Assistant Deputy Minister for Therapeutic Affair, MOH,KSA Disclosure Information Formulary
More informationImportant Considerations for the Introduction of Biosimilars in the U.S. Frank A. Scappaticci, MD, PhD
Important Considerations for the Introduction of Biosimilars in the U.S. Frank A. Scappaticci, MD, PhD Global Clinical Science Leader Genentech, Inc. / F. Hoffmann-La Roche Ltd. November 7, 2013 Outline
More informationRegulatory Issues and Drug Product Approval for Biopharmaceuticals
Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop
More informationOverview of Biologics (Including Biosimilars)
Overview of Biologics (Including Biosimilars) 2015 Sandoz Inc. All Rights Reserved. The material contained in this slide deck may not be altered or reproduced without express written consent from Sandoz
More informationBiosimilar mabs Clinical issues Regulatory perspective
Biosimilar mabs Clinical issues Regulatory perspective EMEA Workshop on Biosimilar Monoclonal Antibodies, MD BMWP Chairman European Medicines Agency (EMEA), UK Paul-Ehrlich-Institut, Germany Mechanisms
More informationTrial-design in biosimilar research: Equivalence or non-inferiority design
Trial-design in biosimilar research: Equivalence or non-inferiority design Prof. Kit C.B. Roes Professor of Clinical Trial Methodology Advisor to MEB-CBG Overview The place(s) of the clinical efficacy
More informationThe Future Role of Biosimilars: An Unknown Frontier in IBD Treatment
The Future Role of Biosimilars: An Unknown Frontier in IBD Treatment Miguel Regueiro, MD, FACG Professor of Medicine Medical Director, IBD Center Senior Medical Lead, Specialty Homes University of Pittsburgh
More informationGlobal Biosimilar Market Trends & Opportunities: 2015 Edition
Global Biosimilar Market Trends & Opportunities: 2015 Edition Global Biosimilar Market Trends & Opportunities: 2015 Edition BioPortfolio has been marketing business and market research reports from selected
More informationTrends in Medication Management. Jayson Gallant, B.Pharm, M.Sc Pharmacist, Health Benefit Management
Trends in Medication Management Jayson Gallant, B.Pharm, M.Sc Pharmacist, Health Benefit Management Agenda Drug Claims Trends Legislative / Public Plan Initiatives Biosimilars Pipeline Focus on Oncology
More informationTOP PAPERS FROM 2016: IBD & BIOSIMILARS CYNTHIA SEOW MBBS(HONS), MSC, FRACP UNIVERSITY OF CALGARY CDDW, BANFF, AB MARCH 5, 2017
TOP PAPERS FROM 2016: IBD & BIOSIMILARS CYNTHIA SEOW MBBS(HONS), MSC, FRACP UNIVERSITY OF CALGARY CDDW, BANFF, AB MARCH 5, 2017 FINANCIAL INTEREST DISCLOSURE (OVER THE PAST 24 MONTHS) Speaker: Janssen,
More informationUpdate on Biosimilars
Update on Biosimilars From Fiction to Formulary Natalie Nguyen, Pharm.D. PGY1 Pharmacy Administration Resident Virginia Commonwealth University Health System Disclosures I have no disclosures or conflicts
More informationThe evidence for switching stable patients to Inflectra
The evidence for switching stable patients to Inflectra Professor Silvio Danese Symposium co-chair Date of preparation: March 2017 PP-IFA-GLB-0551 Disclosures Silvio Danese has served as speaker, consultant
More informationBiosimilars an update
Biosimilars an update Darren Roberts Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists Clinical pharmacology and toxicology, St Vincent s Hospital (Sydney) Nephrology,
More informationInmunogenicidad de Biológicos/Biosimilares
Inmunogenicidad de Biológicos/Biosimilares Gilberto Castañeda Hernández Departamento de Farmacología Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional Ciudad de México
More informationReference Standards to Support the Development of Biosimilars
Reference Standards to Support the Development of Biosimilars Jane Robinson & Adrian Bristow Jane.Robinson @nibsc.org Adrian.Bristow@nibsc.org The National Institute for Biological Standards and Control,
More informationvfa/vfa bio Position Paper Biopharmaceuticals Original Products and Biosimilars
vfa/vfa bio Position Paper Biopharmaceuticals Original Products and Biosimilars vfa/vfa bio Position Paper Biopharmaceuticals Original Products and Biosimilars EXECUTIVE SUMMARY vfa and vfa bio represent
More informationBIOSIMILARS view from Slovak Medicine Regulatory Agency on topic
BIOSIMILARS view from Slovak Medicine Regulatory Agency on topic SARAP SUKL: Regulatory conference, Bratislava, Slovakia, June, 3, 2013 PharmDr. Jan Mazag Director of State Institute for Drug Control,
More informationNDA Advisory Services Ltd
Declaration of Interest statement: Paul Chamberlain has received Consulting fees from different companies in respect of strategic and operational advice relating to biopharmaceutical development; he is
More informationImplementation of Biosimilars: The Good, the Bad, the Ugly September 13, Learning Objectives. Audience Response 9/3/2018
Implementation of Biosimilars: The Good, the Bad, the Ugly September 13, 2018 Monica Macik, PharmD, BCPS, BCOP Clinical Pharmacy Specialist Hematology/Oncology Eskenazi Health Indianapolis, IN Karen Smethers,
More informationLAW: Primer on biosimilar agents
AND AN ONGOING CE PROGRAM OF THE UNIVERSITY OF CONNECTICUT SCHOOL OF PHARMACY AND DRUG TOPICS 2 CPE CREDITS EARN CE CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM Educational Objectives After participating
More informationA Physician s consideration towards Biosimilars. João Eurico Fonseca
A Physician s consideration towards Biosimilars João Eurico Fonseca Disclosure I received unrestricted research grants or acted as a speaker for Abbvie, Amgen, BMS, Celtrion, Celgene, Janssen, MSD, Novartis,
More informationBaek, Kyung-min. Recombinant Protein Products Division. Ministry of Food and Drug Safety
Baek, Kyung-min Recombinant Protein Products Division Ministry of Food and Drug Safety About Ministry of Food and Drug Safety Regulation for Biosimilar Principle of Biosimilar Approach Status of Biosimilar
More informationConsiderations and reflections concerning implementation of biosimilar MABs in the clinic - focus on trastuzumab
Considerations and reflections concerning implementation of biosimilar MABs in the clinic - focus on trastuzumab Head of Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital PhD MD
More informationComparability to establish Biosimilarity
Comparability to establish Biosimilarity CMC Strategy Forum Europe 2014, Sorrento, Italy Jan Visser, Head Global Analytical Characterization & Bioanalytics Sandoz Biopharmaceuticals, Hexal AG, Germany
More informationQuality of biologicals
Quality of biologicals K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Typical biotech manufacturing
More informationHospira at a 5/20/2015. The World s Leading Provider of Injectable Drugs and Infusion Technologies
Sumant Ramachandra, MD, PhD SVP and Chief Scientific Officer Alliance for Health Reform May 20 th, 2015 Hospira at a glance The World s Leading Provider of Injectable Drugs and Infusion Technologies Market
More informationPatiënten-onderzoeken naar overstappen Wat leren we van trials en registries
3rd Dutch National Biosimilar Symposium 12 April 2018, Rotterdam Patiënten-onderzoeken naar overstappen Wat leren we van trials en registries Liese Barbier PhD researcher KU Leuven MABEL Fund Disclosure
More informationSurvey 1 - Rheumatoid Arthritis (RA) Patients perception on originator biologics and biosimilars
SUPPLEMENTAL MATERIAL - Perception of originator biologics and biosimilars: a survey amongst Belgian rheumatoid arthritis patients and rheumatologists BioDrugs Eline van Overbeeke 1, Birgit De Beleyr,
More informationBiosimilars in the EU
Biosimilars in the EU Information guide for healthcare professionals Prepared jointly by the European Medicines Agency and the European Commission Table of contents Foreword 2 Summary 3 Biological medicines:
More informationNHS BioValue: The Potential for a Landmark UK NHS Real World Evidence Study on Biosimilars
NHS BioValue: The Potential for a Landmark UK NHS Real World Evidence Study on Biosimilars Angela McFarlane Market Development Director, QuintilesIMS Angela.McFarlane@QuintilesIMS.com Copyright 2016 QuintilesIMS.
More informationBiosimilar Monoclonal Antibodies: Registration Requirements. Henry M. J. Leng
Biosimilar Monoclonal Antibodies: Registration Requirements Henry M. J. Leng Disclaimer This presentation is given in my personal capacity and represents only the author s personal views and does not represent
More informationcontinuing education for pharmacists
continuing education for pharmacists Biologics and Biosimilars Volume XXXV, No. 8 Mona T. Thompson, R.Ph., PharmD, BCPS Dr. Mona Thompson has no relevant financial relationships to disclose. Goal. The
More informationBiologicals & biosimilars; addressing the needs of patients and payers. The Role of Functioning Competitive Markets
Biologicals & biosimilars; addressing the needs of patients and payers The Role of Functioning Competitive Markets Agenda Why do patients and payers need biosimilars? How can we increase the uptake of
More informationEvolving U.S. Biosimilars Landscape
Evolving U.S. Biosimilars Landscape A Medical Affairs Perspective By Thao Sutter and Bryan Katz Syneos Health Consulting 2018 Syneos Health. All rights reserved. Introduction The U.S. biosimilar landscape
More information