It's no secret that biosims have failed to take off in the U.S. like some market watchers had hoped. Now, new Novartis CEO Vas Narasimhan is calling for cooperation from all players in the supply chain to help biosims gain traction.
In a Forbes guest post, Narasimhan said a tangle of intellectual property rules and rebating strategies have limited uptake for the copycat biologics. Legal snarls have stymied the launch of multiple approved biosims, he noted; nine have gained FDa approval, but only three have hit the market. Still, he said, biosims represent an "undeniable opportunity" to increase patients' access to biologic treatments and deliver value to the healthcare system.
Meanwhile, two of the marketed biosims, Inflectra from Pfizer and Renflexis from Merck, are struggling against Johnson & Johnson's Remicade. Pfizer has sued, arguing J&J tied rebates on existing Remicade patients to the stipulation that payers don't use biosimilars, shutting Inflectra out.
Pfizer said such "exclusionary contracts" are anticompetitive, while Johnson & Johnson countered that Pfizer isn't offering enough value to win business. In a media briefing this week, Pfizer executives said they don't want preferred access on formularies. Rather, they want equal access and the opportunity to compete.
To boost the U.S. biosim market, Narasimhan is calling for simpler regulations and guidance to make the path to market more clear. He's also calling for an end to the "rebate wall" to "create better contracting models that help patients access to cost-saving biosimilar treatments."
The "rebate wall," he says, favors big branded biologics at the expense of biosimilars and their potential savings. Market watchers have long suggested the contracting setup could hinder biosim uptake.
Narasimhan's comments come right on the heels of AbbVie's settlement with Samsung Bioepis that ensures the latter company's Humira biosim—to be marketed by Merck & Co. in the U.S.—won't launch before 2023. That deal followed an agreement with Amgen staving off that company's biosim before 2023. Humira is the world's bestselling med, generating $18.4 billion last year, and AbbVie has helped its growth along with repeated price increases.
With the latest AbbVie deal, Jefferies analyst Ian Hilliker wrote that it's "increasingly unlikely" that other biosim developers will be able to negotiate for U.S. launch dates earlier than 2023. Jefferies is predicting global Humira sales will peak at $20.9 billion next year, even after Amgen won U.S. biosimilar approval in 2016.
In their biosimilars briefing with reporters this week, Pfizer executives said AbbVie's Humira situation is "unique" because the drug boasts so many patents, making it risky for biosimilar entrants to launch. Still, they said they will try to get their biosim to market "as soon as possible."