Key Regulatory Considerations for the Development of Biosimilar Pharmaceutical Products
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2014, Vol 4, Issue 2
Abstract
Regulatory authorities are faced with different kinds of challenges when dealing with biosimilar products compared to other conventional generics. This is one of the reasons which made the FDA in the U.S. to delay authorizing biosimilars which have been in existence in Europe since 2005. Legal and scientific issues were sorted out in 2007 thus allowing the U.S. to approve Omnitrope and Valtropin. The BPCI Act was signed into law in 2009 and it was responsible for creating biological drug approval. Other important components of biosimilars are data exclusivity and patents whose aim are to preserve knowledge and innovation. They recognizes that an originator invest a lot of time and resources before producing a product. This document ends by discussing the challenges and opportunities of producing biosimilar products, and the issues to be considered before developing a biosimilar product.
Authors and Affiliations
Samrat Sisodia
Keywords
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