Pfizer's new Inflectra biosim data puts J&J's Remicade on notice in Crohn's

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Pfizer's Remicade biosimilar drug Inflectra was approved for Crohn's at launch, but it now has disease-specific data that could quell skepticism about its use in those patients.

Pfizer has scored new Crohn’s disease data that could give its Remicade biosimilar, Inflectra, some new oomph for its market-share fight, one of the first head-to-head U.S. matchups between a top biologic drug and a biosimilar alternative.

Launched late last year, Inflectra came out of the gate approved for several uses, including moderate-to-severe Crohn’s. But until now, Pfizer hasn’t had Crohn’s-specific data, and Johnson & Johnson has used that fact to argue against uptake of the biosim, an analyst said.

That argument could now be moot. In the new head-to-head study against the J&J drug, Inflectra (infliximab-dyyb) met its primary goal: Demonstrating that its results and side effects were comparable to Remicade’s in Crohn’s patients.

The measurements were taken at the six-week mark. The 214-patient trial is intended to run for 54 weeks, with patients in each arm randomized to switch (or not) to the other drug at week 30.

Pharma-watchers are keeping a close eye on Inflectra, the first biosimilar alternative to Remicade launched in the U.S. It made its stateside debut at a list price 15% lower than the brand, Pfizer said; negotiations with payers may have yielded further discounts.

J&J maintains that biosims “are not generics,” and execs say that they’re not expecting a stampede to Remicade knockoffs in the U.S. Plus, J&J has some discount programs of its own. When Inflectra launched, the company said Remicade’s market is already “extremely competitive” on price and that J&J was working up “innovative contracts” to “utilize the full breadth” of its portfolio.

“We feel well prepared to face the biosimilar,” Joaquin Duato, pharma group chairman, said on the company’s Q3 earnings call.

Merck & Co. might have hoped the same thing in Europe, where it has Remicade marketing rights. Thanks to that biosim competition, Merck’s Remicade sales were down in 2016 by 29% to $1.26 billion. In some countries, biosims marketed by Pfizer’s partner, Celltrion, have drained away 40% of the brand’s share.

The U.S. market is different, obviously, given that the country has no single-payer healthcare system or cost-effectiveness body to negotiate prices. But U.S. payers have said they’re eager to adopt biosimilars to save money, and in some cases—as with Eli Lilly and Boehringer Ingelheim’s Lantus insulin biosim Basaglar and Novartis’ Neupogen biosim Zarxio—has tossed branded meds off-formulary in favor of their new knockoffs.

That’s not a universal move, and prescribing remains in physicians’ hands. Unlike traditional generics, biosimilars aren’t readily substitutable at the pharmacy for their reference brands, at least for now. So J&J plans to continue touting the brand to doctors as the first choice, and the company has maintained that Remicade won’t quickly lose ground to biosimilar competition in the U.S., because patients are satisfied and brand-loyal.

Pfizer, though, has its own marketing plans, and the new Crohn’s data could become part of them. It removes a question mark that at least one regulator has raised. As Bernstein analyst Ronny Gal wrote in a Tuesday note, Health Canada suggested that a particular variation in Crohn’s might “lead to different activity” for Inflectra in that disease. “This data was used by J&J to argue against adoption of the biosimilar,” Gal wrote. “Now the data exist for the biosimilar to prove the opposite.”