FDA issues biosimilar final guidance

May 1, 2015

FDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

FDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

“The final guidances reflect the FDA’s consideration of comments from a broad range of stakeholders and are intended to provide predictability and further clarity on scientific and regulatory considerations for sponsors initiating biosimilar development programs,” said FDA spokesperson Stephen King.

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FDA released these draft guidances for public comment in February 2012 and each of the guidance dockets received between 40 and 60 comments from stakeholders, including patient groups, healthcare providers, pharmaceutical and biotechnology companies (and their trade associations), and other interested parties. The agency held a public hearing in May 2012 to obtain additional public input on the draft guidance documents and solicit public input on topics for future policies regarding biosimilars. The public hearing docket received more than 40 comments from stakeholders related to the guidances and to other issues (such as topics for future policies on biosimilars).

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FDA has issued 6 draft guidance documents to date related to the implementation of the Biologics Price Competition and Innovation Act of 2009 that explain the FDA’s current thinking on key scientific factors and regulatory issues involved in submitting applications for biosimilar products to the FDA for evaluation.

The agency is expected to issue the following draft guidances in 2015 per the CDER guidance agenda:

  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

  • Considerations in Demonstrating Interchangeability to a Reference Product

  • Labeling for Biosimilar Biological Products

  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity.

“While guidances are an important tool for industry, we do not need final guidances to make decisions on biosimilar applications,” King said. “While there are no requirements in the law for issuing guidances before taking an approval action, we have issued 6 draft guidances for industry. FDA makes decisions based on relevant laws and scientific data.  If the applicant submits the data to support an approval, then, consistent with the BPCI [Biologics Price Competition and Innovation] Act, we can make a decision regardless of whether we’ve issued final guidance.”

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