FDA Guidance Outlines How to Assess Biosimilar Similarity

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By Greg Langlois

Biosimilar sponsors hoping to get their products licensed are getting new guidelines describing how they should analyze whether their offerings are similar enough to already licensed ones.

The Food and Drug Administration sought comments on a draft guidance that’s designed to help sponsors conduct a required analytical assessment of a proposed biosimilar’s similarity to a licensed biologic product (or “reference product"). A notice was published in the Sept. 22 Federal Register (82 Fed. Reg. 44,425).

“I think it’s another step toward memorializing the answer to the regulatory riddle—how similar is similar enough to be biosimilar?” said David Fox, a partner with Hogan Lovells, in an interview with Bloomberg BNA. “The statute tells us the answer to that question is ‘highly similar,’ but there’s a lot leftover for the agency to guide the industry on.”

The Biologics Price Competiion and Innovation Act of 2009 (BPCIA) created an abbreviated approval process for biosimilars, a biological product that is highly similar to an FDA-approved one. To be approved, a proposed biosimilar must not have any clinically meaningful safety or effectiveness differences from the reference product, the FDA explained.

Lessons Learned

The FDA can roll out biosimilar guidance now after learning lessons from its initial approvals, Fox said. The agency has approved five since Congress passed the BPCIA.

“This is an aggregation of their experience so far,” Fox said. “It’s memorializing what they’re seeing in the rearview mirror, instead of laying down new pavement.”

The most recent draft guidance is part of a series of documents the FDA is putting out to implement the BPCIA. It is a companion to biosimilar guidance the FDA issued for industry in April 2015. The agency also issued draft guidance in January on demonstrating a biosimilar’s interchangability with a reference product.

The newest draft guidance explains what types of information a biosimilar sponsor should obtain about the attributes of the reference product, how that information should be used developing a similarity assessment plan, and what statistical approaches should be used for evaluating similarity.

“One of the important things that’s in there is that the FDA is still showing an openness to flexibility for situations where the guidance they’re putting out may not fit for a particular product,” said Patrick Gallagher, a partner with Duane Morris LLP, in an interview with Bloomberg BNA. “[T]he biosimilars arena is not really one-size-fits-all.”

For example, the guidance says biosimilar sponsors should obtain 10 lots of the reference product to use as a comparison with 10 lots of its own product, with the samples from varied time frames, Gallagher said. But if that’s not possible, he said, the FDA is open to alternatives if an applicant explains why.

The guidance should make the biosimilar industry “more comfortable” with getting into the biosimilar market, Gallagher said.

“When the very first applications were filed, it was a bit of an unknown what the FDA was going to require, and the companies that jumped in early were really blazing the trail,” he said. “Companies that were a bit more reluctant to be trailblazers were sort of holding back.”

The Pharmaceutical Research and Manufacturers of America told Bloomberg BNA in a statement that it is reviewing the guidance and “appreciates FDA’s efforts to provide greater certainty in the development of biosimilar products and enhance the competitive marketplace.”

Other Issues

Although helpful to biosimilar industry players, the FDA should put more focus on larger issues impeding the development of new products, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines. Those issues include granting biosimilars distinguishable names and winning over reluctant physicians and pharmacists, he said.

The FDA, while slower to address biosimilars than regulators in some other countries, should play a prominent role in addressing those issues, Reilly told Bloomberg BNA.

“We have advantages with the FDA being the gold standard as a regulator,” he said. “That means that they have responsibility to also be a leader.”

“The thing that gets lost in the equation,” he said, “is that the real overall goal should be to lower the costs of biologic medicines and increase access for patients.”

The deadline for submitting comments on the new draft guidance is Nov. 21.

To contact the reporter on this story: Greg Langlois in Washington at glanglois@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The draft guidance is available at http://src.bna.com/sMl.

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