Samsung Bioepis Co. has kicked off efforts to get marketing authorization for its third biosimilar product in Europe.

“Samsung Bioepis filed a lawsuit in the U.K. on March 24 challenging a number of patents held by U.S. pharmaceutical company AbbVie on Humira, the reference drug of Samsung’s SB5, and this inditaes that Samsung has embarked on the process to make way for the market debut of the Humira biosimilar,” said an official at Samsung Bioepis on Monday.

Humira, a biologic drug to treat rheumatoid arthritis, is the world’s best-selling drug, having generated sales of $12.9 billion in 2014. Humira is indicated for as many as 13 disorders, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, severe axial spondyloarthritis, active pediatric Crohn disease, hidradenitis suppurativa, juvenile enthesitis-related arthritis and severe chronic plaque psoriasis.

Samsung Bioepis presented data from a 24-week clinical trial of SB5 at the American College of Rheumatology (ACR) annual meeting last year. AbbVie recently extended patent rights on some indications to 2022 as the protection of its key material patent approached expiration. Samsung Bioepis stood up against the company’s move with a legal challenge, saying the patent extension is a tyrannical act to protect its product from competition.

If Samsung Bioepis wins marketing authorization for SB5, it will be able to sell all of its biosimilar versions of the world’s top three arthritis drugs in Europe. The company already won approval for Benapali and is awaiting approval for Flixabi. The market value of the three original drugs amounts to $34.6 billion.

If Samsung Bioepis wins the patent court battle, Samsung will be recognized in technology to avoid patents. But AbbVie is expected to fire back as Humira represents 61 percent of the U.S. company’s annual revenue.

By Lee Dong-in

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