FDA, FTC send message to biologics makers at competition workshop

US drug and antitrust regulators have signalled their intent to crack down on anti-competitive behaviour in the biologics and biosimilar industries, in an effort to bring down prices.

The US Food and Drug Administration (FDA) and the US Federal Trade Commission (FTC) held a joint workshop on promoting competition in the biologics industry in Maryland yesterday, March 9.

Recently-appointed FDA commissioner Stephen Hahn said the agency had observed efforts by “manufacturers to delay competition for biosimilar products”, as well as the “publication of materials that seem designed to create uncertainty about biosimilars and discourage patients and health care providers from using them”.

“These behaviours have the potential to put innovation at risk, erode public confidence in the product, weaken efforts to lower health costs through competition, and, ultimately, undermine advances in healthcare as potential treatments and cures are unavailable or go unrealised,” Hahn said.

These concerns were echoed by FTC chairman Joe Simons, who warned biologics manufacturers against disseminating information about biosimilar competitor products which could “mislead patients and physicians into believing the biosimilar is not as safe or as effective as the reference biologic”.

“Such deception might violate both consumer protection and antitrust laws,” Simons added.

The comments come amid growing scrutiny on the often prohibitively high cost of biosimilar drugs.

A Clarivate Analytics report published last month indicated that more than half of new ‘blockbuster’ drugs will be biologics.

One such drug is Valrox, owned by BioMarin Pharmaceutical, expected to be the “most expensive drug ever to reach the market” at a list price of $2.5 million—$3 million per treatment.

BioMarin applied for a Biologics Licence Application for Valrox in December.

The FTC chairman said the antitrust regulator was also on the lookout for manufacturers impeding access to samples needed to develop biosimilar competitors.

“Our collaboration with the FTC is the next step in our efforts to end these types of counterproductive activities,” added Hahn.

The two agencies made similar statements last month, with Hahn likening the increased focus on biologics competition to the crackdown on ‘pay-for-delay’ settlements involving generic drugs.

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