The Food and Drug Administration on Feb. 9 issued some guidelines for industry on how to develop so-called biosimilar products.
The agency has been open to receiving applications for such products since a specific approval pathway was created under the Affordable Care Act in March 2010, but without specific guidance, there have been no such applications so far, according to FDA officials.
"These draft documents are designed to help industry develop biosimilar versions of approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a statement.
The three "draft guidances" the agency issued "should help biosimilar developers move forward to understand the agency’s expectations," and also provide a "transparent, clear, predictable regulatory pathway," said Dr. Rachel Sherman, director in the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research.
Biosimilars are biological products that are highly similar to an already approved biological product, according to the FDA.
The first draft guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product," is considered the key document, said Dr. Sherman. It outlines the basic requirements for how a company can show that its product is similar to the biologic that’s already approved. Developers will have to primarily go through a series of analytical tests to prove similarity.
The FDA would then weigh that information in determining whether the product would require further animal or human testing, said Dr. Sherman.
A biosimilar will not automatically be deemed interchangeable with an existing product. That is a separate determination, she said, noting that it would require further safety and efficacy testing.
So far, the agency has received requests for consultations from 35 companies seeking to develop biosimilars for 11 reference products, said Dr. Sherman. The agency has held 21 meetings. But there have been no formal applications for approval.
The two other guidance documents were, "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, which gives "excruciating detail" about the analytics to be used, said Dr. Sherman, and "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009."
The latter document contains many of the questions companies have asked in previous consultations with the FDA, said Dr. Sherman. She expects that to be updated as the process evolves. The FDA will hold a public meeting to gather comments on the draft guidances, Dr. Sherman said.
Dr. Richard Dolinar, a clinical endocrinologist in Phoenix and chairman of the Alliance for Safe Biologic Medicines said in a statement that the organization welcomed the draft guidance documents as "an important step forward in expanding access to existing biological therapies."
ASBM members include companies concerned about biosimilar encroachment, such as Amgen and Genentech, and the Biotech Industry Organization, and along with several patient advocacy groups.