FDA working on a 'dozen' policies to boost copycat biotech drugs

[March 29, 2018] By Ben Hirschler and Yasmeen Abutaleb

NEW YORK (Reuters) - The U.S. Food & Drug Administration is working on around a dozen actions to boost use of cheaper versions of expensive biotech medicines, the head of the agency Scott Gottlieb said on Wednesday.

The United States has lagged behind Europe in use of so-called biosimilars, to the frustration of FDA policymakers who are starting to approve such products but who are seeing other impediments to getting them to consumers.

Biological drugs for treating serious conditions such as cancer and rheumatoid arthritis are complex molecules made inside living cells.

"There's no silver bullet here in terms of trying to make this market really go gangbusters. I think this is going to be a slow build," Gottlieb told CNBC's Healthy Returns conference in New York.

"We're going to be coming out with a set of policies, multiple policies, about a dozen policies that I think incrementally will each move the ball in a direction trying to create more avenues for biosimilar competition."

His comments followed a speech earlier this month when he criticized the health industry for "Kabuki drug-pricing constructs".

One specific action Gottlieb said the FDA was working on was a plan to make it harder to tweak original branded biological medicines so that drug makers can extend patents. This should make it easier for makers of copies, who are able to sell their versions once patents expire.

Gottlieb also said he was concerned about the impact of deals like the CVS Health purchase of Aetna Inc on the ability of pharmaceutical companies to block the entry of cheaper copycat drugs.

As the pharmacy benefit managers, which administer drug benefits for employers and health plans and also run large mail-order pharmacies, and the drug supply chains consolidate, Gottlieb said, they are making it easier for pharmaceutical companies to block access to drugs produced by the generic companies that are legally entitled to create cheaper copycat versions of the medicines.

"We don't have direct purview over it but we do have something to say about it and we're going to be speaking to the PBMs about it," Gottlieb said.

Cigna Corp also agreed recently to buy pharmacy benefit manager Express Scripts Holding Inc.

PFIZER VS J&J

A key battleground in the biosimilars fight is Remicade, a treatment for rheumatoid arthritis and Crohn's disease marketed by Johnson & Johnson.

Pfizer, which sells a cheaper biosimilar version, has sued J&J over its Remicade contracts with health insurers, arguing that they are anti-competitive. It contends J&J is offering discounts on Remicade in exchange for essentially excluding Pfizer's drug from insurance coverage, keeping it out of the hands of doctors and patients.

J&J says Pfizer's suit is without merit.

(Reporting by Ben Hirschler, Yasmeen Abutaleb and Caroline Humer; Editing by Frances Kerry)

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