EMEA Workshop on the feasibility of Biosimilar monoclonal Antibodies WELCOME AND KEYNOTE PRESENTATION Xavier Luria, Head of Safety & Efficacy Sector European Medicines Agency (EMEA)
Welcome to a broad range of experts from: • Industry - Innovator and Biosimilar • Academia • Scientific Regulators
Objective The objective of this workshop is to discuss the feasibility and key aspects of the scientific development and authorisation of monoclonal antibodies via the Biosimilar regulatory pathway.
Biosimilar development in the EU • Legislation – Directive 2001/83/EC, as amended (2004/27/EC) Article 10.4 • Structures – Biosimilar Task Force (2004-2007) (EMEA transversal group - regulatory / legal / quality / safety / efficacy / PhV competences) – Biosimilar Working Party (BMWP) (est. 2005, multidisciplinary) • Implementation – Initial guidance (2Q 2004)
Current Biosimilar Guidelines – Summary Overarching Guideline (CHMP/437/04) Defines principles “Guideline on Similar Biological Medicinal Products” Biotechnology- derived proteins Quality General guidelines Non- clinical Quality / Safety Efficacy Clinical IFN- α LMWH Insulin Somatropin GCSF Epoetin Non- Product class Non- Non- Non- Non- Non- mAbs ? clinical specific data clinical clinical clinical clinical clinical requirements Clinical Clinical Clinical Clinical Clinical Clinical
Products evaluated CHMP – First Scientific Advice for Biosimilar development (2003) – First positive Biosimilar CHMP opinion (2006 Omnitrope) – First marketed Biosimilar in the European Union (2006)
Scientific Advice - - Biosimilars Biosimilars Scientific Advice Biosimilar Scientific Advices 18 16 4 14 Number of applications 12 10 2 FU first 8 3 3 1 13 6 9 4 6 6 6 2 4 4 0 2003 2004 2005 2006 2007 2008 2009 Year
Scientific Advice - - Biosimilars Biosimilars Scientific Advice Scientific Advices for Biosimilar products 25 20 Number of SA 15 No of SA No of Products 22 10 15 14 5 8 7 6 6 5 5 5 4 4 4 4 4 4 0 n n n s H n m r i i i o b e W p t l e u i r a h t o s s e t o M M r a O n f t p r a r L I e E g m t l n i F o I S Therapeutic categories Other refers to follitropin, PTH and blood factor biosimilars
Biosimilar MAA Procedures MAA Procedures Biosimilar (Status - - June 2009) June 2009) (Status 1 Omnitrope (somatropin) Sandoz Authorised 2 Valtropin (somatropin) Biopartners Authorised 3 Alpheon (interferon alfa) Biopartners Negative 4 Binocrit (epoetin alfa) Sandoz Authorised 5 Epoetin alfa Hexal (epoetin alfa) Hexal Authorised 6 Abseamed (epoetin alfa) Medice Authorised 7 Silapo (epoetin zeta) Stada Authorised 8 Retacrit (epoetin zeta) Hospira Authorised 9 Insulin Marvel Short (human insulin) Marvel Life Sci’ Withdrawn 10 Insulin Marvel Intermediate (human insulin)Marvel Life Sci’ Withdrawn 11 Insulin Marvel Long (human insulin) Marvel Life Sci’ Withdrawn 12 Filgrastim Ratiopharm (filgrastim) Ratiopharm Authorised 13 Ratiograstim (filgrastim) Ratiopharm Authorised 14 Biograstim (filgrastim) CT Arzneimittel Authorised 15 Tevagrastim (filgrastim) Teva Authorised 16 Filgrastim Hexal (filgrastim) Hexal Authorised 17 Zarzio (filgrastim) Sandoz Authorised
EMEA Experience with monoclonal Antibodies (mAbs) Centralised 35 MAA 25 Procedure: evaluated authorised Scientific 157 12 84 mAbs procedures Advice / PA: authorised on mAb Orphan Drug 54 ODD 82 2 Designation: granted authorised requests
Summary • Biosimilar MAA portfolio and related guidelines continue to grow • Increasing interest in the development of Biosimilars (Scientific Advices) • EMEA gained comprehensive experience for certain types of monoclonal antibodies • EU Regulators experience important reference for other territories (Japan (first marketed Biosimilar ), Canada, WHO, Malaysia, US)
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