The U.S. Food and Drug Administration has just issued three draft guidance documents on bio-similar product development to help the U.S. industry to develop products like this.
In comparison with most prescription drugs that are manufactured through chemicals processes, biological products are usually made from human and/or animal materials and include a large variety of products for the treatment of diseases and health conditions, such as vaccines, blood and blood components, gene therapies, tissues, and proteins. In contrast, bio-similar products are biological products that are almost identical to an already approved biological product despite of minor differences in clinically inactive components, and which show no clinically significant differences to an approved biological product, in terms of the safety, purity, and potency.
Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research commented:
"When it comes to getting new bio-similar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process. These draft documents are designed to help industry develop bio-similar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
On the 23 March 2010, President Obama signed The Patient Protection and Affordable Care Act, which amended the Public Health Service Act under section 351(k), to create shorter approval pathways for biological products that have proven highly similar (bio-similar), to FDA-licensed biological products, or which are interchangeable with FDA-licensed biological products.
Under the new approval scheme, biological products are granted approval based on evidence that they are bio-similar to, or interchangeable with, an already FDA approved biological product (reference product).
The FDA has developed the following three guidance documents based on which key scientific and regulatory factors they believe should be considered for the submittal of applications for bio-similar products to the agency. Public comments on their draft guidance documents are invited:
Scientific Considerations in Demonstrating Bio-similarity to a Reference Product:
The draft guidance is intended as an aid to companies to prove to the FDA that a proposed therapeutic protein product is bio-similar to a reference product for the purpose of submitting an application, called a "351(k)" application. This draft guidance provides details of a risk-based "totality-of-the-evidence" approach, which the FDA intends to use for assessing submitted data and information to help determine the bio-similarity between the proposed product and the reference product. The FDA has outlined in its draft guidance that it recommends a step-by-step approach in the development of bio-similar products.
Quality Considerations in Demonstrating Bio-similarity to a Reference Protein Product:
This draft guidance offers an overview of analytical factors that are to be considered when evaluating the bio-similarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. For example, the significance of extensive analytical, physico-chemical and biological characterization in proving that the proposed product is highly similar to the reference product despite minor differences in clinically inactive components.
Bio-similars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009:
The third draft guidance offers answers to common questions from those interested in developing bio-similar products, addressing questions that could potentially arise in the early stages of product development, for instance, how to request meetings with the FDA, addressing differences in formulation from the reference product, how to request exclusivity, as well as other topics.
The FDA is inviting public comments on the guide documents. Instructions on how to submit comments will be announced in an upcoming Federal Register notice. The agency will consider the information submitted by the public at the finalization of the guidance documents.
Written by Petra Rattue