Follow-on protein products

FDA (2004), CDER Public Workshop Scientific Considerations Related to Developing Follow-On Protein Products, September 14-15, 2004. Available at http // www.fda.gov/cder/regulatory/follow on/default.htm publicworkshops (accessed... 

Food and Drug Administration (2005), Scientific considerations related to developing follow-on protein products. Available at http //www.fda.gov/cder/meeting/ followOn/followOnPresentations2 2005.htm and http //www.fda.gov/cder/ meeting/followOn/followOnPresentations.htm (accessed May 2005). 

Webber, K. (2005), Relevant terminology. A presentation conducted at the Public Workshop on the Development of Follow-On Protein Products, Sept. 14, 2004, available http //www.fda.gov/cder/meeting/followOn/followOnPresentations.htm, accessed Feb. 2, 2005. 

A special regulatory issue regarding biotechnology-based pharmaceuticals relates to the generic products or follow-on protein products, as patent protections for a number of first-generation biotechnology-based protein products are about to expire. Because of... 

Woodcock J, Griffin J, Behrman R, et al. The FDA s assessment of follow-on protein products a historical perspective. Nat Rev Drag Disco 2007 6(6) 437-442. 

Hagman and Sivertsson discussed the work performed at Pharmacia and Upjohn52 on monitoring and controlling bioprocesses. They followed the protein production-derived form Chinese hamster cells (CHO-cells) in a 500-1 reactor over a 3-month period. The diagrams of the flow cell and pumping/NIR system are displayed, and the logic behind the work outlined. External and on-line calibrations were performed. 

REGULATORY CONSIDERATIONS IN APPROVAL OF FOLLOW-ON PROTEIN DRUG PRODUCTS... 

Gerald W. Becker, SSCI, West Lafayette, Indiana, Biotechnology-Derived Drug Product Development Regulatory Considerations in Approval of Follow-On Protein Drug Products... 

FDA has received inquiries concerning how a sponsor may demonstrate scientifically that its protein pharmaceutical product is similar enough to a FDA-licensed product to obtain approval, without conducting certain studies that would otherwise be necessary. Because of the scientific complexity of protein pharmaceutical products, FDA is conducting an extensive pub-Hc dialogue on the scientific issues relating to the development and approval of such products. In September of 2004, and again in February of 2005, FDA sponsored pubhc workshops on scientific and technical considerations related to the development of follow-on protein pharmaceutical products (http //www. fda. go v/cder/mee t-... 

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