The Strategic Guide to

Follow-On Biologics

Addressing the Scientific, Regulatory, Legal and Business Challenges of Next Generation Biologics, Biogenerics and Follow-On Biologics

Thursday, June 24, 2004

About

An estimated $10-15 Billion in biologics are due to come off patent in the next two years, opening the door for "generic" competition. Whether they're called "follow-on", "next generation" or "generic biologics", pharmaceutical, biotech and generics companies all have a stake in this lucrative market.

If you need to maximize your existing biologics patents and to protect your product lifecycles, or if you want to gain entry into the existing market, what are the best strategies for addressing the scientific, regulatory and legal issues surrounding follow-on biologics?

The FDA is currently focusing on guidelines for industry addressing the application process for follow-on biologics; these guidelines are due to be released shortly. Agency efforts are concentrating on assessment of the necessary pre-clinical and clinical studies, as well as the analytical characterizations to assure that follow-on products meet safety and efficacy standards. Can the review process be expedited without a compromise in patient safety?

There are possible changes on the legislative front as well. Both the House and Senate are addressing industry pressure regarding follow-on biologics. Will there be subsequent changes to Hatch-Waxman to facilitate follow-on biologics or biogenerics?

The impending competition of follow-ons is the impetus for innovation in the biologics arena. Companies are now looking towards next-generation biologics to either retain or capture market share. How will this "double-edged sword" affect comparability and substitutability?

This American Conference Institute publication was developed to give you the latest information on these and other critical issues surrounding follow-on biologics.

This timely publication will give you focused and in-depth analysis from an exceptional faculty comprised of biologics industry leaders from innovator and non-innovator pharmaceutical and biotechnology companies and their outside counsel.

Insights on key issues include:

  • Tactics for overcoming immunogenicity
  • Assessing product comparability
  • The pathway to biogenerics in the US
  • The intersection of patent and regulatory issues for follow-on biologics
  • Market protection and lifecycle management
  • IP strategies for biologics

Highlights include a legislative update with insights from Patrick Morrisey, Deputy Staff Director of the House Committee on Energy & Commerce and Steven Irizarry, Counsel to Senator Judd Gregg of the Senate HELP Committee.

Anthony R. Mire-Sluis, PhD, Principal Advisor for Regulatory Science and Review, Office of Biotechnology Products, CDER, FDA will bring you up-to-date on US regulatory initiatives regarding follow-on biologics. There will also be an update on EMEA Regulatory Guidelines for Biologics.

Contents & Contributors

About

An estimated $10-15 Billion in biologics are due to come off patent in the next two years, opening the door for "generic" competition. Whether they're called "follow-on", "next generation" or "generic biologics", pharmaceutical, biotech and generics companies all have a stake in this lucrative market.

If you need to maximize your existing biologics patents and to protect your product lifecycles, or if you want to gain entry into the existing market, what are the best strategies for addressing the scientific, regulatory and legal issues surrounding follow-on biologics?

The FDA is currently focusing on guidelines for industry addressing the application process for follow-on biologics; these guidelines are due to be released shortly. Agency efforts are concentrating on assessment of the necessary pre-clinical and clinical studies, as well as the analytical characterizations to assure that follow-on products meet safety and efficacy standards. Can the review process be expedited without a compromise in patient safety?

There are possible changes on the legislative front as well. Both the House and Senate are addressing industry pressure regarding follow-on biologics. Will there be subsequent changes to Hatch-Waxman to facilitate follow-on biologics or biogenerics?

The impending competition of follow-ons is the impetus for innovation in the biologics arena. Companies are now looking towards next-generation biologics to either retain or capture market share. How will this "double-edged sword" affect comparability and substitutability?

This American Conference Institute publication was developed to give you the latest information on these and other critical issues surrounding follow-on biologics.

This timely publication will give you focused and in-depth analysis from an exceptional faculty comprised of biologics industry leaders from innovator and non-innovator pharmaceutical and biotechnology companies and their outside counsel.

Insights on key issues include:

  • Tactics for overcoming immunogenicity
  • Assessing product comparability
  • The pathway to biogenerics in the US
  • The intersection of patent and regulatory issues for follow-on biologics
  • Market protection and lifecycle management
  • IP strategies for biologics

Highlights include a legislative update with insights from Patrick Morrisey, Deputy Staff Director of the House Committee on Energy & Commerce and Steven Irizarry, Counsel to Senator Judd Gregg of the Senate HELP Committee.

Anthony R. Mire-Sluis, PhD, Principal Advisor for Regulatory Science and Review, Office of Biotechnology Products, CDER, FDA will bring you up-to-date on US regulatory initiatives regarding follow-on biologics. There will also be an update on EMEA Regulatory Guidelines for Biologics.

Contents & Contributors

PROTEIN DRUGS: HIGH MARKET VALUE
David Szymkowski, PhD, Xencor

THE MANUGACTURING PROCESS: A SIGNIFICANT DETERMINANT OF THE BIOLOGICAL PRODUCT
Basant Sharma, PhD, Centocor/Johnson & Johnson

TECHNICAL AND ANALYTICAL CHALLENGES IN CHARACTERIZATION AND COMPARABILITY ASSESSMENT OF BIOLOGICS
David Fei, PhD, Chiron Corporation

TECHNICAL & ANALYTICAL CHALLENGES IN BILOGICAL CHARACTERIZATION OF BIOTHERAPEUTICS
Meena Subramanyam, PhD, Biogen Idec

ASSESSING & IMPROVING IMMUNOSAFETY OF FOLLOW-ON & NEXT GENERATION BIOLOGICS: FROM RATIONAL DRUG DESIGN TO PRECLINICAL EVALUATION
David E. Szymkowski, Xencor

PROTEIN ENGINEERING TO PRODUCE NEXT GENERATION THERAPEUTICS
Mark A. Goldsmith, MD, PhD, Genencor

FDA INITIATIVES ON ‘FOLLOW ON' BIOTECHNOLOGY PRODUCTS
Anthony Mire-Sluis, CDER/FDA

UPDATE ON THE REGULATORY FRAMEWORK IN THE EU
Peter Bogaert, Covington & Burling

BIOGENERICS: SAFETY ASSESSMENT AND COMMENTS ON MINIMUM DATA REQUIREMENTS
James D. Green, PhD, Biogen Idec, Inc.

GENERIC BIOPHARMACEUTICALS
Steve Bende, PhD, Science and Policy Strategies, LLC and GphA

THE LEGAL AND REGULATORY CASE FOR FOLLOW-ON BIOLOGICS: INNOVATOR AND GENERIC ROUNDTABLE
Paula Campbell Evans, Palmer & Dodge LLP
Kerry Flynn, Transkaryotic Therapies, Inc.
Reza Green, Novo Nordisk, Inc.
Geoffrey Levitt, Wyeth Pharmaceuticals
Michael J. Werner, Biotechnology Industry Organization

THE INTERSECTION OF REGULATORY AND PATENT ISSUES FOR FOLLOW-ON BIOLOGICS
Paula Campbell Evans, Palmer & Dodge LLP

FOBS AND BIO
Michael J. Werner, Biotechnology Industry Organization

THE CHALLENGE OF MARKET PROTECTION FOR BIOLOGICS
Gregory J. Glover, JD, MD, Ropes & Gray



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