The Potential and Possibilities for BioGenerics Thursday, May 28, 2009 Bruce A. Leicher, Sr. VP and General Counsel. Momenta Pharmaceuticals, Inc. . Momenta Pharmaceuticals, Inc. Founded 2001 – Cambridge, MA – ~165 Employees Analytical platform developed at MIT in 1990s
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The Potential and Possibilities for BioGenerics
Thursday, May 28, 2009
Bruce A. Leicher, Sr. VP and General Counsel
Momenta Pharmaceuticals, Inc.
Structure-Process: Leverage technology to design and control manufacturing process
Characterization is critical to design and ensure robust understanding and control of manufacturing process for complex biopharmaceuticals
Integrated Momenta Characterization Analytics
Levelofprocess and product knowledge (characterization) provided for the FOB will be key when FDA sets the criteria for Biogeneric and Biosimilar approvals.
Biological and Clinical Testing, in the absence of sufficient product knowledge, will be inadequate to qualify structural differences and/or uncertainty between the FOB and the Innovator – to justify interchangeability.
Steven Kozlowski, PhD
Director, Office of Biotechnology Products, OPS/CDER/FDA
Competition that Allows Extended Brand Sales
1st Generic Launch
1 Generic: ~15%
3 Generics: ~50%
Brand Earning Potential
7+ Generics: ~90%
Markets with limited competition have potential for significant economics
Momenta Position – FOB Legislation
Clear Regulatory path to Interchangeability
No mandatory requirement for Clinical Trials
No mandatory requirement for public Guidance Documents
FDA to determine regulatory framework and criteria,
to be Driven by theScience
Appropriate period of Data Exclusivity for innovator
Certain and Fair Patent Process pre-Approval
– Ensure Incentives for Analytical Innovation –
– Ensure Highest Product Quality and Patient Safety –
-Encourages Innovative R&D Investment in Unmet Needs-