FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Janssen’s Remicade Biosimilar Infringement Case Against Samsung Bioepis Dismissed

Dec. 11, 2017

Janssen Biotech and Samsung Bioepis jointly requested that Janssen’s patent infringement case be dismissed following the Supreme Court’s ruling earlier this year on the biosimilar approval process. The New Jersey federal court agreed to the motion last week.

Janssen filed the case in May to defend its blockbuster drug Remicade (inflixmab) from biosimilar competition. Samsung Bioepis’ version, Renflexis (infliximab-abda), was approved in April across several of the treatment’s indications.

Renflexis is the second Remicade biosimilar approved by the FDA, after Celltrion’s Inflectra (infliximab-dyyb). Remicade, with approvals in 16 indications, brought in nearly $7 billion in sales last year.

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