WASHINGTON, D.C.—Federal regulators are hoping that new biologics will become available to patients at a lower cost under a new act designed to facilitate the development of products intended to be biologically similar to already approved biologic therapies, U.S. Food and Drug Administration (FDA) officials said in a session titled, “Biosimilars Development: Food and Drug Administration Perspective,” at the 2012 ACR/ARHP Annual Meeting, held November 9–14. [Editor’s Note: This session was recorded and is available via ACR SessionSelect at www.rheumatology.org.]
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But the review and approval of such products will depend on the product, how much is known about it, and the quality of the data submitted to the FDA, the officials said.
The Biologics Price Competition and Innovation Act of 2009 (BPCI), approved as part of the Affordable Care Act, is designed to hasten development of products that are proposed to be “biosimilar” to previously approved therapies.
“Biologics have revolutionized the management of many rheumatic diseases,” said Nikolay Nikolov, clinical reviewer with the FDA’s Division of Pulmonary, Allergy and Rheumatology Products (DPARP). “However, the access to these drugs may be limited due to higher price. The abbreviated biosimilars pathway is expected to facilitate development of biosimilar products and provide additional treatment options.”
A product is considered to be biosimilar under the act if it is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency.
The officials described the “stepwise” and “totality of the evidence” approach to the assessment and determination of biosimilarity. The foundation is the extensive analytical characterization of the structure and function of the product. Additional clinical studies might be required to resolve any residual uncertainties that might stem from limitations of the data that are presented or differences observed in the structure and function of the proposed biosimilar product and the reference product.
“The goal is to demonstrate biosimilarity—that the products are highly similar with no clinically meaningful differences,” said Leah Christl, PhD, associate director for therapeutic biologics at the FDA. “The goal is not to independently establish effectiveness and safety of that proposed product. The reference product already did that.”
She added that, “we really want folks to understand their product, their protein, the product that they’re developing, and the key to this is understanding which attributes matter and which don’t.”