By Dr. Richard Dolinar
Chairman of the Alliance for Safe Biologic Medicines
(Published April 5, 2012)


Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused on safety, they failed to provide clarity around what measuring stick the FDA will use to determine if a product is similar. We know that clinical trials could be used to prove that they are trustworthy.

But we need to find the questions that must be answered by manufacturers of biosimilars to make doctors rest easy when prescribing them. Ultimately, we want to have the same confidence in biosimilars that we have in biologics, but that can only happen if the FDA is clear and specific about the standards to which it is holding biosimilar manufacturers and if the data is available to the public.

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