Regulatory and Scientific Issues Related to Developing
Follow-On Protein Products

• Public Workshops
• Citizen Petitions and Responses

During the past several years, there has been increasing interest in the development of follow-on protein products in light of advances in manufacturing technology, process control, and protein characterization. We use the informal term follow-on protein products generally to refer to proteins and peptides that are intended to be sufficiently similar to a product already approved under the Federal Food, Drug, and Cosmetic Act or licensed under the Public Health Service Act to permit the applicant to rely on certain existing scientific knowledge about the safety and effectiveness of the approved protein product. Follow-on protein products may be produced through biotechnology or derived from natural sources. FDA has been considering the circumstances in which review and approval of follow-on protein products may be appropriate.

This Web page provides a compilation of presentations, citizen petitions and related documents, and public comments on scientific and regulatory issues related to the development of follow-on protein products. Additional documents and information will be added as they become available.

Public Workshops

Scientific Issues in Assessing the Similarity of Follow-on Protein Products
December 12-14, 2005
Co-sponsored by FDA, in collaboration with the National Institute for Standards and Technology, and the New York Academy of Sciences

• Agenda
• Meeting Presentations

Follow-On Protein Pharmaceuticals
February 14-16, 2005
Co-sponsored by FDA and the Drug Information Association

• Agenda
• Meeting Presentations
• Transcripts from Public Meeting:
  • February 14, 2005: Plenary Session | Breakout Session A | Breakout Session B | Breakout Session C | Breakout Session D
  • February 15, 2005: Plenary Session | Breakout Session E | Breakout Session F
  • February 16, 2005: Plenary Session

Scientific Considerations Related to Developing Follow-On Protein Products
September 14-15, 2004
Sponsored by FDA

• Agenda (Final) [TXT] [Word]
• Federal Register Notice: [TXT] [PDF]
• Meeting Presentations
• Transcripts from Public Meeting:
• September 14, 2004: Pages 1-100 | Pages 101-200 | Pages 201-300 | Pages 301-321
• September 15, 2004: Pages 1-100 | Pages 101-148
• Comments submitted to Public Docket "Scientific Considerations Related to Developing Follow-On Protein Products" (Docket No. 2004N-0355)

Citizen Petitions and Responses

• "Follow-On Approval of Therapeutic Protein Products" (Docket No. 2003P-0176)
  
• "Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products" (Docket No. 2004P-0171)
  
• "Request for Denial of Approval of NDA 21-426 for Omnitrope (somatropin [rDNA origin] for injection)" (Docket No. 2004P-0231)
• Response to Citizen Petitions
  

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Date created: June 6, 2006

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