Janssen, a pharmaceutical division of multinational medical company Johnson & Johnson, has filed a lawsuit against Samsung Bioepis Co., a biotechnology research and development unit of South Korea’s largest conglomerate Samsung Group, claiming that the Korean firm’s biosimilar autoimmune disease treatment drug Renflexis (infliximab) to be sold in the United States infringed on its patents.

According to the pharmaceutical industry sources on Sunday, Janssen filed a patent lawsuit against Samsung Bioepis in the U.S. District Court of New Jersey court in the U.S. last week, arguing that the Korean firm’s biosimilar has violated three of its patents related to the original drug’s manufacturing process.

Renflexis is a copy of Janssen’s blockbuster drug Remicade, an antibody used to treat rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Remicade was sold 9.3 trillion won ($8.22 billion) worldwide last year.

Janssen’s lawsuit comes in a month after Samsung Bioepis gained marketing approval from the U.S. Food and Drug Administration (FDA) in an attempt to delay the sale of the Korean firm’s biosimilar in the U.S. market that is slated for release in the market by the end of this year.

An official at Samsung Bioepis said the Korean company has anticipated possible legal actions to be taken by the original drug maker, and it will launch the Renflexis in the U.S. as planned.

Janssen has already filed several patent infringement lawsuits against Celltrion Inc., Korea’s top biosimilar drug developer that has made Remsima, another low-cost replication of Remicade.

By Kim Hye-soon

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