Gottlieb calls out 'rigged' system that's hurting biosimilars, pledges FDA fight to boost uptake

FDA commissioner Scott Gottlieb announced agency efforts to help biosim uptake on Wednesday. (FDA)

As biosimilars languish in the U.S. market and much of their potential savings go unrealized, the issue is getting attention from a top government health official. On Wednesday, FDA Commissioner Scott Gottlieb, M.D., blasted a "rigged" contracting system that's hurting uptake and development, pledging agency action to do what it can to amend the situation. 

At the National Health Policy Conference for America's Health Insurance Plans on Wednesday, Gottlieb criticized a system that has disincentivized biosimilar development, saying it's due in part to consolidation. 

Gottlieb noted that of the nine approved biosims in the U.S., only three have reached the market. Patent litigation is often the cause for launch delays after approval. 

Once on the market, biosimilars face more uncertainty due to contracting. Gottlieb said he's worried that a "rigged payment scheme" is already chilling biosim development, according to prepared remarks

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It's a fact Pfizer has faced with Inflectra, its biosimilar to Johnson & Johnson's megablockbuter Remicade. The biosim launched in 2016 and still hasn't captured meaningful share because, as Pfizer put it in a lawsuit, J&J's "anticompetitive" contracts have blocked use of the biosim.

According to Pfizer, J&J has tied rebates on the existing Remicade patient base to the stipulation that payers don't use biosims. J&J responded that it is competing fairly and that Pfizer hasn't offered enough value to win business. 

RELATED: With its Remicade biosimilar stymied by the brand, Pfizer sues Johnson & Johnson for 'anticompetitive' dealmaking  

At AHIP's meeting, Gottlieb called on payers to make decisions that will boost biosim uptake and therefore competition, noting that the FDA will take some of its own steps. 

First, he said, the agency will set up an "efficient path" for how biosim developers can establish interchangeability with reference products. The agency also plans to present a comprehensive biosimilar access plan, he told the audience. 

Further, the FDA is reviewing how it can assist biosim developers conduct "smaller, targeted trials, and bring more biosimilars to market in a much more cost-effective and timely manner," Gottlieb said.

A representative for AHIP said health plans "welcome the introduction of generic biologics, or biosimilars, as a way to give patients quicker access to more affordable medicines." 

But, she said, branded drugmakers "still cause a price problem" by raising list prices ahead of expected competition. Biosim developers react by setting their prices higher than they would without the branded price hikes, she said. 

The result is that the "overall health care system as well as the consumers who need these important therapies won’t reap the much needed savings from biosimilars," AHIP's representative said.

RELATED: What's slowing biosim uptake? Pricing, contracting, clinical doubts and DTC ads 

In response to the remarks, the group that represents PBMs, PCMA, said in a statement it's "unfair to blame payers—who pay 2/3 the cost of drug benefits—for seeking the lowest costs in a marketplace where they have no control over the prices drugmakers set, how quickly FDA approves biosimilars, or when FDA will finalize workable interchangeability guidelines to increase uptake of biosimiliars."

It's no secret that biosims have largely struggled in the U.S. since their introduction. A recent report from Trinity Partners outlined several reasons why that's the case, including rebating strategies, clinical doubts and DTC advertising for brands.  

At the meeting on Wednesday, Gottlieb said the FDA will do its part to educate doctors and patients and reduce clinical doubts about biosims, asking the audience of payer representatives to do the same.

Editor's note: This story was updated with a statement from AHIP.