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Welcome to a broad range of experts from:
- Industry - Innovator and Biosimilar
- Academia
- Scientific Regulators
EMEA Workshop on the feasibility of Biosimilar monoclonal - - PowerPoint PPT Presentation
EMEA Workshop on the feasibility of Biosimilar monoclonal - - PowerPoint PPT Presentation
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 -
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Objective The objective of this workshop is to discuss the feasibility and key aspects
- f the scientific development and authorisation
- f monoclonal antibodies
via the Biosimilar regulatory pathway.
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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)
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Overarching Guideline (CHMP/437/04) “Guideline on Similar Biological Medicinal Products” Biotechnology- derived proteins Epoetin Quality Non- clinical Clinical LMWH Non- clinical Clinical IFN-α Non- clinical Clinical
Current Biosimilar Guidelines – Summary
GCSF Non- clinical Clinical Non- clinical Clinical Non- clinical Clinical Somatropin Defines principles Non- clinical Clinical Insulin General guidelines Quality / Safety Efficacy Product class specific data requirements mAbs ?
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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)
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Scientific Advice Scientific Advice -
- Biosimilars
Biosimilars
Biosimilar Scientific Advices
4 6 6 6 13 9 3 4 1 3 4 2
2 4 6 8 10 12 14 16 18 2003 2004 2005 2006 2007 2008 2009
Year Number of applications
FU first
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Scientific Advice Scientific Advice -
- Biosimilars
Biosimilars
Other refers to follitropin, PTH and blood factor biosimilars
Scientific Advices for Biosimilar products
4 5 15 7 22 6 5 4 4 4 8 6 14 5 4 4
5 10 15 20 25
L M W H S
- m
a t r
- p
i n E p
- e
t i n I n s u l i n F i l g r a s t i m I n t e r f e r
- n
M a b s O t h e r Therapeutic categories Number of SA
No of SA No of Products
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Biosimilar Biosimilar MAA Procedures MAA Procedures (Status (Status -
- June 2009)
June 2009)
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
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Scientific Advice / PA:
84 mAbs 157 procedures
- n mAb
Orphan Drug Designation:
82 requests 54 ODD granted
Centralised Procedure:
35 MAA evaluated 25 authorised
EMEA Experience with
monoclonal Antibodies (mAbs)
12 authorised 2 authorised
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- 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