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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. . 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.

momenta pharmaceuticals inc
Momenta Pharmaceuticals, Inc.
  • Founded 2001 – Cambridge, MA – ~165 Employees
  • Analytical platform developed at MIT in 1990s
  • Initial Focus - Characterization Technology
    • Complex Mixture Molecules: Heparins, Peptides, Biologics
      • Complex Generic Drugs
      • Follow on Biologic Drugs
      • Novel Biopharmaceutical Drugs
      • Molecular Diagnostics and Biomarkers


structural characterization and control of the manufacturing process
Structural Characterizationand control of the Manufacturing Process
  • Characterization of:
    • each species in the reference product
    • its composition and sequence
  • Batch-to-batch variability of the reference product determined
  • “Equivalence Windows” developed
    • Captures inherent variability in manufacturing process
  • Critical to ensure robust understanding of manufacturing process for complex biopharmaceuticals
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







Step 1

Step 2

Step 3

Integrated Momenta Characterization Analytics

  • Product Starting Material
  • Process Parameters
  • Process Controls
  • Process Knowledge
  • Product Quality
  • Quality-By-Design (QbD)


Thorough Characterization Enhances Quality – But is disruptive to the more standard FOBs development approach


Momenta Follow-on-Biologic

Standard Biosimilar

Brand Biosimlar

Brand Biosimlar+

Brand Biogeneric







Product Knowledge







  • Remove uncertainty. Qualify differences. Demonstrate equivalence.
    • Thorough characterization
    • Manufacturing Process Design
    • Product Control and Quality
  • Increased POS for approval
  • Reduced (non)clinical requirements
  • Better commercial differentiation


demonstrating interchangeability can enhance quality
Demonstrating Interchangeability Can Enhance Quality
  • Quality Improvements
    • Identifyingstructural variations associated with side effects
    • Enabling greater precision in identifying “contaminants”
    • Facilitating greater understanding of Manufacturing changes
    • Providing greater understanding of Product “drift”
  • Advances in technology offer the potential for improved manufacturing consistency


FDA should balance the level of chemical characterization with need for additional biological and clinical testing

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


interchangeability with the innovator drug will be key driver to commercial success in the u s
Interchangeability with the Innovator drug will be key driver to commercial success in the U.S.


Therapeutic Alternative


Therapeutic Substitution



Therapeutic Equivalence



Competition that Allows Extended Brand Sales


1st Generic Launch

Limited Entrants

1 Generic: ~15%

3 Generics: ~50%

Retention of

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-

competition investment and innovation challenges
Competition, Investment and Innovation Challenges
  • Hatch Waxman was pro-competitive and pro-R&D
    • Spurred innovation investment in novel, unmet needs rather than 3rd, 4th and 5th entrants or life cycle management in a class of therapy
    • Provided 5 years of exclusivity + patent term extension
    • Permitted transparency for legal clearance of invalid or unenforceable patents prior to launch of the generic
  • Today, there is no legal pathway for generic entry of biologics
    • Key incentive for Investment and Innovation
  • BIO/PhRMA is seeking longer exclusivity as a condition of any new legislation
    • This would impede investment, and entry of competition
    • This is not consistent with the greater number of patents covering the making, using and selling of biologics
    • Drugs have greater competition during their patent lives and less earning potential due to the more limited scope of patent coverage
    • This would reward “less innovative” R&D


patent clearance challenges
Patent Clearance Challenges
  • Hatch-Waxman used the “Orange Book” to identify and facilitate notice of patents that may be challenged as invalid, not infringed or unenforceable
  • To promote competition, the process must enable initiation of the process early enough to allow for a generic launch when the patents expire or are determined not to block a generic
  • Biologics are challenging because of the complex array of patent protection and multiple parties
    • Early identification
    • Early right to sue in advance of data exclusivity (following FDA acceptance of filing)