FDA Issues Guidelines for Biosimilar Drugs

In the United States, the race to produce competitive copies of biologic drugs such as monoclonal antibodies has officially kicked off.

On February 9, the U.S. Food and Drug Administration (FDA) released draft guidelines for approval of biosimilar drugs, defined as products that are “highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences [from] the approved biological product in terms of the safety, purity, and potency.”

“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,” says Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research.

The 2010 Patient Protection and Affordable Care Act directed the FDA to work out approval mechanisms for biologics. Effective in 2014, original biologic reference products will receive 12 years of market exclusivity after their FDA approval.

FDA 351(k) applications for biosimilars “must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and a clinical study or studies, unless the FDA determines, in its discretion, that certain studies are unnecessary,” the guidelines say.

U.S. law gives a period of exclusivity for the first product that is not only biosimilar but interchangeable with the reference product. The bar of FDA approval is higher, considering such questions as whether health care providers or their patients would need instruction to make the switch. “At this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original 351(k) application,” the guidelines note.

While the U.S. market for biosimilars is expected to become the largest by 2020, according to an analysis by IMS Health in Danbury, CT, such agents are already being sold in Europe, India, and other countries.

Pharmaceutical and biotechnology companies worldwide are gearing up for these opportunities. Manufacturers of original products are teaming up with firms that offer expertise in generic products. For instance, Amgen of Thousand Oaks, CA, signed an agreement in December with Watson Pharmaceuticals of Parsippany, NJ, to commercialize oncology biosimilars worldwide.

Development of a biosimilar requires significant technical capability and clinical trial expertise and may cost between $20 and $100 million exclusive of manufacturing plant expenses, says the IMS report.

In the United States, “stringent clinical requirements and an involved, potentially drawn-out procedure for resolving patent disputes are likely to delay the speed of uptake in the near future,” the report adds. “Behind every product patent there are several potential lines of defense for originator companies, including process patents.”

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