Perspectives and considerations related to biological products
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1 Perspectives and considerations related to biological products Dirceu Barbano Director Brazilian Health Surveillance Agency Anvisa Rio August,
2 GECIS Executive group of the health industry complex Work group in Biological products (ANVISA coordination)
3 Economic impacts concerning to Biological Products - Biological products from the welfare ministerial ordinance nº 978/08; - Database: Hospital Information System (SIA/SUS).
4 What are the Biologicals Produtcs? Biological Products 1. BIOMEDICINES 2. MONOCLONAL ANTIBODIES 3. VACCINES 4. BLOOD PRODUCTS
5 Total investment in medicines - SIA/SUS Biological products 2% 98% Synthetic products Investment 41% 59%
6 Total investment in medicines - SIA/SUS Biological Products Biomedicines Total 99% Investment 68% Monoclonal Antibodies Total 1% Investment 32%
7 Considerations related to Biological Products In general, biologicals are complex products: - difficult to characterise; - product quality highly dependent on manufacturing process; - changes in manufacturing process may result in significant changes in safety/efficacy profile.
8 Current legislation Composition of legislation concerning biologicals RDC 46, 05/18/00 Blood products RDC 323, 11/10/03 Probiotic products RDC 233, 08/17/05 Allergenic products RDC 315, 10/26/05 New biological and biological products * Products obtained from animal tissues in discussion.
9 RDC 315/2005 Biologicals covered by the RDC 315/2005: 1. Vaccines 2. Hiperimmune Sera 3. Blood products 4. Biomedicines: - medicines obtained from biological fluids or animal tissues - medicines from biotechnological procedures
10 RDC 315/2005 Biologicals covered by the RDC 315/2005: 5. Monoclonal antibodies 6. Medicines containing live, attenuated or dead microorganisms 7. Probiotics 8. Allergens
11 RDC 315/2005 Biological product (molecule already licensed in Brazil) Finished biological products New biological product (molecule not licensed in Brazil)
12 Review of RDC 315/05 (perspectives) Nowadays: - Same requirements for all categories of biologicals. Perspectives: - Different approach for distinct categories of biologicals; - Specific check-list for the production and quality control of: vaccines, blood products, biotechnologicals and hiperimmune sera; - Possibility of specific regulatory issues by product, establishing manufacturing, quality control, nonclinical and clinical requirements.
13 Review of RDC 315/05 (perspectives) Nowadays: - The company can t include new API production site. Perspectives: - Possibility of Including and/or Changing the API production site. - For companies within the same group and/or performing technology transfer - Proving that products quality, safety and efficacy are not changed through comparative studies
14 Review of RDC 315/05 (perspectives) Nowadays: - There isn t specific regulation about batch size of biologics. Perspectives: - The company could change the batch size in two different situations: inclusion of batch size till ten times of pilot-batch size; inclusion of batch size higher than ten times of pilot-batch size.
15 Review of RDC 315/05 (perspectives) Nowadays: - At the renewal of licensing the company must send repeated documentation. Perspectives: - The company will send just: follow-up stability study; pharmacosurveillance report; up-to-date plasma master file to blood products; proof of product marketing.
16 Review of RDC 315/05 (perspectives) Nowadays: - Clinical trials: Phases I, II and III. - Non-inferiority studies to biological products. Perspectives: - Deeper details about criteria for non-inferiority studies. - Specific requirements for specific categories of products: hiperimmune sera; blood products; medicines derived from fluids or animal tissues.
17 Review of RDC 315/05 (perspectives) Nowadays: - Phase IV studies and/or PSUR when available. - No specific pharmacosurveillance requirements. Perspectives: - Specific pharmacosurveillance programs and or phase IV studies in Brazil for the registration of:. all new biologicals. biologicals products according to the risk - Risk management plan
18 Review of RDC 315/05 (perspectives) Nowadays - Post-licensing changes are discussed at the same way. Perspectives - Classified by risk level:. Low immediately implementation.. Moderate small check-list, faster analysis.. High- deeper analysis, extensive time to decision.
19 Specific legislation for stability studies of biological products RE n 1/2005 Stability legislation used by the biological licensing area; It s not specific for biological products; Since 2005, Anvisa takes part in WHO group that discusses stability for vaccines; Specific legislation for biological products based on international criteria.
20 contacts: phone: or Thanks!
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