FDA Public Meeting on Biosimilar Pathway Implementation November
FDA Public Meeting on Biosimilar Pathway Implementation November 2 -3, 2010 Sumant Ramachandra, MD, Ph. D, MBA Senior Vice President, R&D and Regulatory & Medical Affairs Chief Scientific Officer, Hospira
Hospira A Leader in Biosimilars § Only U. S. company marketing biosimilars • Leading biosimilar EPO (IV & SC) product, Retacrit™, in the EU • Biosimilar filgrastim (G-CSF) product, Nivestim™, approved in the EU and Australia Hospira supports the overarching premise to expand access to high quality, lower cost, life-enhancing and life-saving biologic medicines through the enacted biosimilar approval pathway.
Biosimilarity Modern bioanalytical and protein characterization tools provide the foundation for a science-based determination of biosimilarity. Incremental requirements for non-clinical and clinical data should be evaluated on a caseby-case basis.
Reference Product Use of an EMA-approved reference product in pivotal biosimilar clinical trials should be permitted with bridging data to the USlicensed reference product.
Extrapolation of clinical data from one indication to other indications should be allowed with proper scientific justification.
Interchangeability Clinical data requirements should be scientifically justified, minimize subject exposure to trials and reflect how products will be used in medical practice.
Pharmacovigilance The same pharmacovigilance system should be used for originator biologic and biosimilar products.
Summary § Biosimilarity can be proven by using modern scientific tools to characterize proteins. § Reference products from a single global source can be scientifically justified. § Extrapolation from one indication to other indications should be allowed. § Interchangeability requirements should reflect how products will be used in medical practice. § Pharmacovigilance systems should be the same for biosimilar and originator products.
- Slides: 8