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FDA is working on a "dozen" policies to encourage copycat biotech drugs



NEW YORK (Reuters) – The US Food and Drug Administration is working on about a dozen measures to push ahead with the use of cheaper versions of expensive biotech drugs, said chief executive Scott Gottlieb on Wednesday.

FILE PHOTO: American Food and Drug Commissioner Scott Gottlieb visits an interview at Reuters Headquarters in New York City, USA on October 1
0, 2017. REUTERS / Eduardo Munoz

The United States has lagged behind Europe. Biosimilars, to the frustration of FDA decision makers, who are beginning to approve such products, but who see other obstacles to bring them to consumers.

Biological drugs used to treat severe conditions such as cancer and rheumatoid arthritis are complex molecules that form in living cells.

"There is no silver bullet when it comes to making this market a real gangster, I think it will be a slow build," Gottlieb told CNBC's Healthy Returns conference in New York.

"We will be using a set of guidelines, several guidelines, about a dozen guidelines that I think will gradually pave the way for biosimilar competition."

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

A Special Action Gottlieb said the FDA was working on a plan to make it harder to tweak original branded biological medicine so that drug makers can extend patents. This should make it easier for brokers to sell their versions once the patents expire.

Gottlieb also said he was concerned about the impact of deals such as CVS Health's acquisition of Aetna Inc. on the ability of pharmaceutical companies to block the entry of cheap counterfeit medicines.

According to Gottlieb, pharmacy-use managers who manage medicines for employers and health plans, and also large mail-order pharmacies, consolidate drug companies' access to medicines from generic companies that are legally entitled to cheaper, more generic drug versions create.

"We have no direct influence on that, but we have something to say about it, and we'll talk about it with the PBMs," Gottlieb said.

Cigna Corp. Also Accepts the Purchase of Pharmacy Benefit Manager Express Scripts Holding Inc.

PFIZER VS J & J

An important battlefield in the fight against biosimilars is Remicade, a treatment by Johnson & Johnson for Rheumatoid arthritis and Crohn's disease.

Pfizer, which sells a cheaper biosimilar version, has sued J & J for its Remicade contracts with health insurers because they are anti-competitive. It claims that J & J offers discounts on Remicade, in return for essentially excluding Pfizer's drug from insurance coverage and removing it from physicians and patients.

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

Reporting by Ben Hirschler, Yasmeen Abutaleb, and Caroline Humer; Arrangement by Frances Kerry


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