Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars

Regulatory NewsRegulatory News | 20 September 2017 |  By 

Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance in the US market for its blockbuster Remicade (infliximab) despite recently introduced competition.

First approved in 1998, J&J's tumor necrosis factor-inhibiting biologic is used to treat a range of immune-mediated diseases in almost 500,000 Americans, including for Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis and has been hauling in billions for J&J (about $4.8 billion in US sales in 2016).

Competition for Remicade has come in recent years, with the approval of Pfizer's Inflectra (infliximab-dyyb) in April 2016 and more recently, Merck and Samsung Bioepis' Renflexis (infliximab-abda).
But Pfizer says in its complaint that despite this competition, J&J's brand-name product still controls 96% of the market because of its effective strategies to stall the competition (which Focusfirst reported on two weeks ago, though the theory that manufacturing issues may be partly to blame for the slow Inflectra uptake have since been debunked).

"J&J's exclusionary plan has been remarkably effective at stifling competition: Today, almost no national commercial health insurer provides coverage for Inflectra (except under the spurious ‘fail first' scenario), and the vast bulk of healthcare provider accounts using infliximab (approximately 90 percent) have not purchased Inflectra at all. Despite some coverage by regional and government plans, Inflectra has secured less than 4 percent of total infliximab unit sales in the U.S. as of September 1, 2017," Pfizer contends.

The company also notes that a key to J&J's ability to force insurers to accept its exclusionary contracts is "its denial of rebates to insurers that decline J&J's exclusivity commitments, thereby imposing a substantial financial penalty. In effect, J&J says to insurers, ‘If you want to receive attractive rebates on Remicade for all your existing Remicade patients'—rebates which, for some insurers, run into the tens of millions of dollars annually—'you must agree to not reimburse for Inflectra, or to do so in the most limited of circumstances,'" the complaint notes.

Pfizer also alleges that since FDA approved Inflectra in 2016 and J&J implemented its plan to block biosimilars (J&J contends that the limited uptake of Inflectra is due to its non-interchangeable status, among other reasons) J&J has raised the Remicade list price by almost 9% and increased the amount the US government reimburses for Remicade by more than $190 per infused dose.

J&J, meanwhile, said the Pfizer suit is without merit and the competition will bring down the price of Remicade.



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