Johnson & Johnson lost its court battle to shield Remicade from encroaching biosimilar competition. A U.S. District Judge on Wednesday struck down a key patent on the drug, clearing the way for Celltrion and Pfizer’s Hospira unit to launch their copy of the $4.5 billion drug.
By J&J’s estimation of legal guidelines, that launch could come as early as Oct. 3.
The company plans to appeal--and no wonder. Remicade is a big earner for the company. And given Merck & Co.’s experience in Europe, where it has marketing rights and now competes against biosims, the erosion in brand sales could be swift.
Pfizer’s Hospira unit will be marketing its infliximab biosim, Inflectra, on behalf of its Celltrion partnership.
J&J has maintained that Remicade won’t quickly lose ground to biosimilar competition in the U.S., because patients are satisfied and brand-loyal. But patients may not have the final say-so. Payers are salivating at the opportunity to save money by dropping the original brands in favor of biosimilars, which are expected to sell at prices anywhere from 15% to 30% less.
And if recently released formularies are any indication, they’re not dragging their feet on adopting biosim meds. CVS Health excluded the Amgen brand Neupogen, choosing Novartis’ biosimilar, Zarxio, marketed by its Sandoz unit. The pharmacy benefits manager also nixed Sanofi’s big-selling basal insulin Lantus, putting Eli Lilly and Boehringer Ingelheim’s copy, Basaglar, in its place.
Of course, branded drugmakers can strike back with their own discounts to preserve market share, but that’s a different sort of sales erosion.
In April, Inflectra became the second biosimilar to win FDA approval, and the green light covers a range of indications: Crohn’s, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. At the time, Celltrion officials said they expected the biosim price to come in at 20% to 30% less than Remicade’s brand sticker.
Meanwhile, Celltrion has been tearing it up in Europe with the Remicade knockoff. Merck's quarterly sales of the drug have been sinking steadily quarter by quarter; for Q2, the drug brought in $339 million, down from $455 million the same period last year.
J&J isn’t giving up on protecting Remicade as long as possible. It says it will appeal Wednesday’s ruling and plans to proceed with an appeal at the U.S. Patent & Trademark Office as well. "A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch,” the company said in a statement, reminding Pfizer that, should J&J prevail, the copycat could be on the hook for big damages.
Pfizer has been prepping for the launch, with the exclusivity questions in mind, CEO Ian Read said on the company's Q1 earnings call. "While launch timing of Inflectra will ultimately depend upon a number of factors, such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016," Read said at the time.
- see the J&J release
J&J updates on Celltrion Remicade biosimilar in U.S. outlook with October date
Pfizer cautious on Remicade biosimilar U.S. launch after J&J blast
Can Celltrion's Remicade biosim repeat its EU market-share steal in the U.S.?
Switching study gives Celltrion biosim more ammo in Remicade fight
J&J pooh-poohs threat from Remicade biosim this year