FDA Issues Draft Guidance on Biosimilar Product Development


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FDAlogoThe FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”

The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway—under section 351(k)—for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product.

Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.

The following three guidance documents provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency:

  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

All three documents are available at www.fda.gov. FDA is seeking public comment on the guidance documents, and instructions on how to submit comments will be announced in a Federal Register notice. In finalizing the guidance documents, the agency will consider the information received from the public. ■


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