U.S. Biosimilar Rollout Hasn’t Been That Slow, Attorney Says

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By John T. Aquino

Getting biosimilars to market in the U.S. is actually proceeding much faster than expected, attorneys and industry experts said March 15.David Fox, a partner at Hogan Lovells, Washington, and former associate chief counsel for the Food and Drug Administration, noted the criticism that only four biosimilars have been approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2010, which provides an abbreviated pathway for biosimilar approval. A biosimilar is a large-molecule biologic drug that is highly similar to the brand biologic and is expected to be less expensive.

To get a fuller measure of progress, Fox pointed to contrasts between the BPCIA and the Hatch-Waxman Act, which provided for the abbreviated approval of a generic drug.

“It took 10 to 15 years from when the Hatch-Waxman Act ... was passed for the legal issues to reach the Supreme Court,” Fox said. “Here with the BPCIA, the regulatory process is up and running and the Supreme Court is already reviewing litigation about the interpretation of the BPCIA and is expected to reach a decision in June. The whole thing may seem slow, but, by lawyers’ standards, it’s moving pretty fast.”

Jim Van Lieshout, vice president for market access and pharmacy strategy for Apobiologix, a developer and maker of biosimilars, said, “There are over 60 biosimilars currently before the FDA. There is investment being made in these products, trying to bring them to market. Things are happening, working their way through the legal and regulatory processes.”

The panel discussion, “The Next Drugs: The Future of Biosimilars,” was sponsored by The Atlantic and underwritten by the Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association).

U.S. Approval Is Step by Step

Biologics are complex molecules used to treat diseases such as cancer and hepatitis C. Under the BPCIA’s abbreviated approval process, the biosimilar applicant must demonstrate, by partly relying on data submitted for FDA approval of the brand biologic, that the biosimilar is highly similar to the brand biologic. Relying on the brand biologic’s data can reduce the cost of developing the biosimilar, and this savings can be passed on to the patient.

The dispute the Supreme Court is reviewing is between Amgen Inc., which makes the biologic Neupogen for treating the effects of chemotherapy, and Novartis’s Sandoz, which makes Zarxio, a biosimilar of Neupogen ( filgrastim) and the first product approved under the BPCIA. It concerns interpretations of the statute that affect how quickly the biosimilar gets to market.

The biosimilar applicant can seek additional FDA review that the product is interchangeable with the brand biologic, canceling the requirement that pharmacists get physician authorization before switching the patient to the biosimilar drug.

Pricing and Naming

The panel discussed a number of issues related to biosimilars. Fox addressed cost savings from biosimilars and their pricing. “Competition will change pricing over time,” he said. “The law Congress passed is really a competition and innovation act—hence the name. Where pricing lands will be determined by how durable the biosimilar product is in the marketplace.”

The FDA Jan. 12 released final guidance on the naming of biological products, including biosimilars, that proposes biologics and biosimilars have nonproprietary or proper names that share a core drug substance name and an FDA-designated suffix composed of four lowercase letters that is unique for each product.

Fox, noting that some have referred to the suffix as “nonsensical,” said: “There is unanimity across the industry about the suffix: Nobody likes it.”

Van Lieshout said the suffix may cause confusion in the industry. “But it’s there for pharmaceutical diligence, for tracking.”

Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said: “The ACS has no position on the naming guidance. But I agree that traceability is important. Understanding where a biosimilar came from and who made it is essential for a substitution decision.”

Conservative Interchangeability Approach

The FDA also issued a draft guidance on how applicants can receive an interchangeability designation for biosimilars. The agency in a March 15 Federal Register notice extended the deadline for comments for another 60 days until May 19 (82 Fed. Reg. 13,819).

Fox said the FDA guidance provides clarity. “They took a conservative approach. They outlined how you design a study step by step, clarifying concerns.”

Van Lieshout said, “Aspects of it are excellent. But there are still questions, how do you do the switching? Europe doesn’t have an interchangeability designation. The U.S. is only place in the world looking at interchangeability.”

Lichtenfeld said: “The whole focus is on establishing confidence in interchangeability so you know it works.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

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

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