Safety Assurance in Focus at FDA Hearing on Biosimilar Guidance and Policy Refinement

The balance point between wider patient access and safety assurance was among the issues receiving particular attention at a public hearing held by FDA in May to get further feedback on where it needs to go in its regulation of biosimilars.

The hearing followed in the wake of FDA’s issuing of a trio of guidances to help steer industry through the new biosimilar approval pathway (IPQ “The News in Depth” February 13, 2012).  The public comment period on those guidances ended in April, and the hearing was intended to give stakeholders a chance for additional input on the guidances and what the agency should prioritize in its development of future policies.

Over 40 organizations provided comments to the agency on the three guidance documents during the comment period (IPQ “The News in Depth” July 25, 2012), and many of the same stakeholders again highlighted their main concerns at the May forum.

An additional seven stakeholders that did not comment on the guidances provided their views to the agency at the hearing: ● the American Pharmacists Association (APhA) ● the Biotechnology Information Institute ● CBR International ● Duke University School of Medicine ● the European Generic Medicines Association (EGA)● PAREXEL, and ● the Pharmaceutical Care Management Association (PCMA).

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