Celltrion preps for its first US biosimilar application with Janssen lawsuit

In the lawsuit​, Celltrion said it’s on an “inevitable collision course” with Janssen as it expects US FDA approval of its anti-inflammatory Remsima biosimilar by early 2015 to treat a whole host of conditions ranging from rheumatoid arthritis to psoriasis.

Celltrion claims in its most recent lawsuit that Janssen is attempting to “improperly extend its monopoly after its initial patents expired​” for Remicade in 2014.

In its complaint, Celltrion argues that Janssen “has employed a variety of manipulative legal and other tactics” to extend its patents on Remicade, which earned Janssen $7.6B in 2012, to 2018, which would mean the company has patent exclusivity for 27 years.

“Because Celltrion expects to face patent infringement allegations from Janssen, Celltrion wants to start the adjudicative process regarding the invalidity and unenforceability of Janssen’s patents​,” the company says. “This will enable Celltrion to immediately avail itself of the processes available in the federal judiciary to discover information relating to Janssen’s patents​.”

And the timeline for court action seems necessary as Celltrion says that denying it “the opportunity to litigate declaratory judgment claims now would delay Celltrion’s access to the judicial system for about 10-12 months.​”

Celltrion is not new to the field of biosimilars - Remsima was the first monoclonal antibody biosimilar to be approved in the EU​ last July, and Celltrion also has won South Korean​ approval for another biosimilar for Roche’s breast cancer drug Herceptin.

Second Lawsuit​

The Celltrion is the second lawsuit to use the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which is the pathway created for the submission and approval of biosimilars under a so-called Section 351(k) application. 

According to Kurt Kast, an attorney at Hyman, Phelps and McNamara, Sandoz previously filed suit against Amgen and Roche over patents covering Enbrel, a treatment for rheumatoid arthritis, but that suit was thrown out because Sandoz had yet to file a biosimilar application with the FDA.

In its appeal in March, according to Kast​, Sandoz said that the previous ruling “completely deprives federal courts of jurisdiction over any declaratory judgment action implicating a biosimilar product until after the FDA had already approved the product—a serious error that undermines the BPCIA’s stated purpose of advancing competition for biologic drugs​.”

But Celltrion has its final pre-filing meeting scheduled with the FDA this month for Remsima, which means it is closer to approval than the Sandoz biosimilar,according to media outlets​.

Both cases will clearly set the path for future biosimilar launches, according to Kast.