Sector News

Gottlieb calls out 'rigged' system that's hurting biosimilars

March 7, 2018
Life sciences

As biosimilars languish in the U.S. market and much of their potential savings goes unrealized, the issue is getting attention from a top government health official. On Wednesday, FDA commissioner Scott Gottlieb 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 of America’s Health Insurance Plans on Wednesday, Gottlieb criticized a system that has disincentived 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.

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 its product.

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.

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.

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.

By Eric Sagonowsky

Source: Fierce Pharma

comments closed

Related News

December 3, 2022

Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability

Life sciences

Monday, the French pharma giant officially moved into its new global home base in Paris, dubbed La Maison Sanofi. The 9,000-square-meter (about 96,875-square-foot) facility comprises two historic buildings and will host around 500 employees, the company explained in a release.

December 3, 2022

As CEO Schultz eyes retirement, Teva taps former Sandoz head Francis as its next leader

Life sciences

On the first day of the new year, former Sandoz chief Richard Francis will take the reins from Schultz, who is hanging up his CEO hat to retire on Dec. 31, Teva said Monday. The news comes a little more than two weeks after Teva publicly said it was looking for Schultz’s replacement.

December 3, 2022

General Electric sets healthcare division spinoff plans

Life sciences

General Electric Co. set the terms for the spinoff of its healthcare division, putting an initial value of roughly $31 billion on the soon-to-be-public company. The Boston conglomerate plans to split into three separate public companies by early 2024. Following the healthcare spinoff, it plans to separate its aerospace business from its power and renewable-energy units.