Biosimilars: business opportunities beyond the EU and the US

Transcription

1 Biosimilars: business opportunities beyond the EU and the US Fernando de Mora, PhD, MBA Professor Department of Pharmacology, Therapeutics and Toxicology Universidad Autónoma de Barcelona SPAIN Universidad Autónoma de Barcelona 1

2 Biosimilars beyond the EU and the US Overlooking the WW regulatory scenario Regulation and market: a return ticket Opportunities and partnerships Summing up Overlooking the WW regulatory scenario Regulation and market: a return ticket Opportunities and partnerships Summing up Biosimilars beyond the EU and the US 2

3 The WW biologics regulatory scenario 3 regulatory zones Highly regulated: EU, USA, Japan, Canada, Australia BIOSIMILARS Not-highly regulated: Rest of the World Non-biosimilar-non -original Biologics (NON-SIMILIAR BIOLOGICS or NSB) Moderately regulated Lowly regulated The Non-Similar Biologics (NSB) regulation Low to moderate REGULATION NSB Non-innovative biological products Copy biotherapeutic products Non-original Biologics Intended copies Non-comparable biologics etc.. Not proven to be BIOSIMILARS DRIVERS Economic reasons (less resources) Patent protection (weak) Local industry (regional-international) More affordable Patients access Patients at a higher risk (than EU, US... patients) Ethical? Fair for the patient? 3

4 Non-similar biologics (NSB): Impact on public health? Difficult to assess Precarious PHARMACOVIGILANCE systems Praditpornsilpa K, Tiranathanagul K et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney International, 80, 88 92, 2011 Mohammad Amir S, Behrouz V, Shiva S et al. Neutralizing antibodies in multiple sclerosis patients on weekly intrasmuscular Avonex and biosimilar interferon beta-1ª (CinnoVVex): comparing results of measurements in two different laboratories. J Imm Met. 388: 46-48, 2013 Kikuzubam ( rituximab-like ) in México? Withdrawn from market Health alert The regulatory walk : A WW trend towards EMA/WHO (1) The Elephant s regulatory walk Towards EMA-like Regulatory pathway From 2008 To 2014 Awareness being raised (authorities + physicians) STILL A LONG WAY TO GO EMA as the reference agency for biosimilars Regulatory walk undertaken in many countries (Biosimilar Generic) 4

5 The regulatory walk : A WW trend towards EMA/WHO (2) Jordan Guatemala Saudi Arabia Egypt Chile ETC... Perú Brasil México Costa Rica Colombia Argentina India... EMA Took the lead WHO: Paves the way SBP guidelines (2010) Regulatory expectations & risk assessment (2014) Meetings (Seoul 2010) + OTHER NO Way back Increasing regulatory convergence Regulatory walk led by Emerging economies The World Bank data/figures: Large emerging economies with robust/emerging biotech industry: *...Share of growth of biologics in 2012 was 14.7% despite share of sales was 7,5%; the piece of the pie will get bigger in emerging markets... Latam Pharma Market Brasil: 15 billion $ US México: 12 billion $ US Venezuela: 6 billion $ US Argentina: 5 billion $ US Colombia: 5 billion $ US Chile: 1.8 billion $ US Perú: 1.2 billion $ US Ecuador: ~1 billion $ US Ongoing regulatory debate in those countries (and others): Located between low-regulated and high-regulated countries *Rickwood S, Di Biase S - IMShealth White Paper. Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market ( 5

6 Biosimilars beyond the EU and the US Overlooking the WW regulatory scenario Regulation and market: a return ticket Opportunities and partnerships Summing up Regulation versus market (1) What is going on in non-highly regulated countries? Original biotech products Non-similar biologics (NSB) Biosimilars? Co-exist Very low penetration so far A different market scenario a different market debate Changes the market balance of power Changes players positioning Changes drivers and barriers to entry 6

7 Regulation versus market (2) Original products: viewed as safe and efficacious, but unaffordable NSB : viewed as affordable but clinically doubtful (by some) The perfect storm for biosimilars: less expensive than originators, but equally safe and efficacious However, biosimilars 20-30% discount still Non-affordable NSB WILL STILL ACCOUNT (FOR YEARS) FOR THE GLOBAL BIOLOGICS SALES IN THESE COUNTRIES Drives/Barriers to entry (1) Market actors perception Physicians outlook on biosimilars Perception on biosimilars build over last years as quality products - in relation to NSB (NO debate over biosimilars safety/efficacy) Innovator industry Position in favor of EMA-like biosimilar regulation / Share goals-interest with biosimilar companies Same concerns regarding NSB (share adversary ) Pharmacovigilance system, traceability...(awareness) May change in the mid-to-long run with biosimilars penetration (moving target) 7

8 Drivers/Barriers to entry (2) National Regulatory Authorities (NRA)? Moderate resistance (depends on country): - economic pressure / need patient access...what s the trade off? - protection of local-regional players (e.g. Brasil?) Economic rationale Medical rationale Need to acknowledge risk for the patient Regulatory effort in progress (not quite yet EMA-like) -Regulatory oversight needed (applied?) - Education-training to regulators...for dossier assessment - Lack of experience / knowledge of biosimilars among healthcare actors - Save elsewhere (e.g. do not re-do tests...) Overlooking the WW regulatory scenario Regulation and market: a return ticket Opportunities and partnerships Summing up Biosimilars beyond the EU and the US 8

9 Partnerships with local-regional industry: a market aim (1) *Non original market grows faster than innovator biologics*, But Non-similar biologics limited to 20% of the biologics market...share of growth of biologics in 2012 was 14.7% despite share of sales was 7,5%; the piece of the pie will get bigger in emerging markets... Source: IMS Health MIDAS, MAT way trade India China Brasil México Argentina Russia Etc. Alliances with local-regional industry: a market aim (2) 2-way partnership between EU-present biosimilar companies and local-international industrial partners PARTNERSHIP 1 Targeting low-to-medium regulated countries To optimize EU companies launch of biosimilars in emerging countries Europe PARTNERSHIP 2 Targeting highly regulated countries Alliance with Local international companies targeting highly regulated markets 9

10 PARTNERSHIP 1 Biosimilars launch in emerging economies Enter emerging countries (and less emerging countries) Niche for biosimilars positioning Less expensive than innovators + same safety/efficacy Substitutability/interchangeability? INN prescription / traceability? Pharmacovigilance? Debate triggered by biosimilar/innovator co. Alliances with local-regional industry for marketing / distribution (e.g. Oli-Med (Latam) / Celltrion) Sales force training + PV plan needed Regulatory alignment with EMA viewed as beneficial to local-regional players: agencies-government willingness towards EMA-like regulation PARTNERSHIP 2 local-regional players in highly regulated countries EMERGING COUNTRIES HAVE Biotech know how Financial robustness Government backup (Taiwan, México, Brasil...) EMERGING COUNTRIES SEEK Regulatory experience/know how Technical/analytical capabilities Marketing know how ( strategy?) Exponential increase of their market potential 10

11 Partnerships: a WIN-WIN strategy EU Biosimilar companies Partnerships with local-regional companies for biosimilar DEVELOPMENT*-MARKETING under EU / WHO standards Market reasons (global rather than local perspective): objective market (WW) / RETURN Consequences Medical impact: safety-to-efficacy profile Regulatory reasons (raise awareness): willingness of national agencies of emerging countries to comply with high regulatory standards *Added value of products already launched in those countries? Restudied for biosimilarity under EMA, hence lower risk? (Rough clinical preliminar assessment: ) Moving towards a convergent regulatory landscape Regulation influences market dynamics Agreements between EU-present Biosimilar companies & Local-regional industry beyond EU/US Market expecation force / influence REGULATORY CHANGE in low-to-medium regulated countries 11

12 Biosimilars beyond the EU and the US Overlooking the WW regulatory scenario Regulation and market: a return ticket Opportunities and partnerships Summing up Biosimilars: business opportunities beyond the EU and US SEEING BEYOND TOMORROW BUSINESS DEVELOPMENT POTENTIAL? Partnerships EU-present biosimilar companies - players from emerging countries : a strategic move towards market uptake and WW regulatory alignment - To launch biosimilars in emerging countries - To co-develop biosimilars and build a portfolio for highly regulated regions Partnerships will have a social-ethical impact: Patients rights European Commission (EC) and EU national governments: back EU biosimilar companies/partnerships to prevent the forecasted globalization of competition from companies from emerging markets? 12

13 Gracias Fernando de Mora, PhD, MBA Professor Department of Pharmacology, Therapeutics and Toxicology Universidad Autónoma de Barcelona SPAIN Universidad Autónoma de Barcelona 13