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Four guidelines for industry offer useful tools for manufacturers

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FDA Compliance

New Guidance From FDA Helps Manufacturers Develop Biosimilars

Four guidelines for industry offer useful tools for manufacturers

Published: Thursday, May 28, 2015 - 12:20

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

In early March, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), which is used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start, and the FDA is pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. The FDA is also working hard to help those manufacturers bring more biosimilars to the market.

During the past few weeks, the FDA has released four guidances for industry—useful tools to help manufacturers navigate the new terrain of biosimilar development.
One assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.
A second focuses on the analytical studies that demonstrate that the product is “highly similar” to an existing biological product, which supports the demonstration of biosimilarity.
A third guidance answers common questions about the biosimilar development and application process, and contains information intended to provide a better understanding of the law that allows biosimilars development.
A fourth, still in draft form—which means the FDA is accepting public comment—answers a variety of additional questions that have arisen regarding the biosimilars development process.

Each of these guidances was developed to help industry more efficiently and effectively develop new biosimilars for patients in need.

Many of the FDA’s most important but also expensive drugs are biological products. These are used to treat patients who have a variety of serious and life-threatening medical conditions, including rheumatoid arthritis, psoriasis, diabetes, and cancer.

Having more approved biosimilars is good for public health. The FDA looks forward to continuing to help manufacturers develop these important products.


About The Author

FDA’s picture


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.