Remicade patients are OK to switch to Celltrion's biosim, study shows, as Pfizer gears up for U.S. rollout

By Carly Helfand Oct 20, 2016 8:05am

Celltrion is hoping patients make the jump from Johnson & Johnson and Merck blockbuster Remicade to its biosimilar, Remsima--and now it has real-world data to support a switch.

In an independent Phase IV study sponsored by the Norwegian government, Remsima kept disease from worsening just as well as its reference product in patients who'd been stable on Remicade for at least 6 months before the switch. In the Remicade arm, 26.2% of patients saw their disease worsen, while 29.6% of Remsima patients did--a difference small enough for researchers to dub the copy noninferior.

Biosimilars such as Remsima have the potential to save healthcare systems significant sums of money, but this can only happen if prescribers are confident that the biosimilar is genuinely comparable to the reference product. "This study adds to the body of real-life evidence from the clinic that switching people to biosimilar infliximab is effective and well tolerated across the range of different conditions we prescribe it for,” study co-author Jørgen Jahnsen said in a statement.

It’s a win for Celltrion--and U.S. partner Pfizer, which is gearing up with the Korean drugmaker to launch its infliximab product next month as Inflectra. On Tuesday’s Q3 conference call, Johnson & Johnson’s execs cited the stability of 70% of patients on the med as a reason they won’t jump ship. If the companies continue racking up evidence that biosimilars won’t disrupt that stability? That could throw a wrench in J&J's plans.

That stable-patients stat isn’t the only reason, however, J&J execs have stressed as a Remicade defense. They’ve also pointed to Remicade’s patient assistance program as a differentiator, for one.

But even if U.S. patients do ultimately flock to the knockoff--as they have in Europe, where Merck has felt the bleeding on its top line--some analysts think J&J will be relatively safe, at least in the near term.

The impending biosim launch “is an understandable source of concern,” Barclays analyst Geoff Meacham wrote in a Tuesday note to clients, “but our quick math indicates that the potential downside risk to 2017 earnings is relatively limited.” If U.S. Remicade sales decline by 10% next year, “we estimate that JNJ could still achieve the current consensus mean EPS of ~$7.10 ... without requiring significant op ex changes.”

Meanwhile, the new data should help Celltrion continue its market-share grab from Merck by adding to the growing pile of real-world evidence in Remsima's favor. Earlier this year, Celltrion said that through 10 real-world studies spanning 600 irritable bowel disease patients in 8 countries, Remsima proved no less safe or effective for patients who switched to the biosim from Remicade.