July 13, 2012

The Food and Drug Administration released the first draft guidance on Biosimilar Products early February. The draft specifically contains 3 guidance documents on (1) Scientific Considerations; (2) Quality Considerations; and (3) Biosimilars: Questions and Answers Guidance. The issued guidance aims to help the pharmaceutical industry comply with the requirements under the BPCI Act and to successfully prove that their product is biosimilar to a biologic product approved by the FDA. The guidance raises many questions in the industry that have to be answered, including the cost of complying. 

Joseph A. Mahoney, Mayer Brown LLP

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