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FDA Issues Draft Guidance on Biosimilar Product Development

Public comment sought on three documents

Published: Monday, February 13, 2012 - 14:30

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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, the FDA has taken an innovative approach in supporting their development at every step of the process,” says Janet Woodcock, M.D., 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.

Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human or animal materials.

A biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency.

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. These FDA is seeking public comment on these draft guidance documents, which are listed below.

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”: The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application, called a “351(k)” application, to the FDA. This draft guidance describes a risk-based “totality of the evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.

“Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”: The draft guidance provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes the importance of extensive analytical, physicochemical, and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.

“Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”: The draft guidance provides answers to common questions from people interested in developing biosimilar products. The question-and-answer format addresses questions that may arise in the early stages of product development, such as how to request meetings with the FDA, addressing differences in formulation from the reference product, how to request exclusivity, and other topics.

The FDA will seek public comment on the guidance documents and instructions on how to submit comments will be announced in an upcoming Federal Register notice. In finalizing the guidance documents, the agency will consider the information received from the public.

For more information, visit the following links:
FDA: Biosimilars
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

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FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.