Dead set on defending its top drug, Johnson & Johnson is taking South Korea’s Samsung Bioepis to federal court on claims it is violating Remicade patents and refusing to participate in a patent dispute resolution process established for biosimilars.
In a lawsuit filed in the United States District Court in New Jersey, Janssen says Bioepis is violating three patents with its biosimilar version of Remicade, J&J’s top seller, which had nearly $5 billion in U.S. sales last year. J&J’s suit asks the court to block the launch of the copy and compel Bioepis to follow the process. It also asks for damages.
For its part, a Bioepis spokesperson told Reuters the company is “confident” it’s not infringing Janssen’s patents.
"We will take all necessary measures against Janssen's attempts to violate patient rights and deny patient access to effective, lower cost treatment options,” Bioepis told the news service.
The situation harkens back to the high-profile biosim case under review at the Supreme Court between Amgen and Novartis’ Sandoz unit. Argued last month, that case centers on whether biosimilar companies should be required to hand over their full FDA approval applications to the makers of the original branded product, and when biosim companies are able to provide “notice” of their intent to market a biosim, thus triggering a six-month waiting period.
J&J says Bioepis provided marketing notice too early and is opting out on the patent dispute resolution process, which has “made it impossible” for the New Jersey drug giant to assess potential patent infringement. A Janssen spokesperson said the suit is a "necessary first step so that we may conduct the proper analyses."
Bioepis has partnered with Merck & Co. for the launch, expected in October after an FDA approval last month triggered the six-month waiting period on the med, dubbed Renflexis. It’s the second Remicade biosim to win FDA approval behind Pfizer and Celltrion’s Inflectra, which hit the U.S. market last October at a 15% discount to the brand.
So far, though, J&J has seen “very little” biosim erosion from the lone competitor, execs reported during a first-quarter conference call. That could change with three players vying for a huge market opportunity, a prospect J&J is hoping it can avoid with the latest legal filing.
After the FDA approved Samsung’s copy, Renflexis, last month, Bernstein analyst Ronny Gal wrote that with a "second biosimilar entering, we expect the market to shift to more of a land grab approach coupled with sharper price declines.”
Biogen has rights to Bioepis’ Remicade biosim in Europe and launched the med there last September.