Novartis launches third-to-market Remicade copy in Germany

Thomson Reuters

By John Miller

ZURICH (Reuters) - Novartis launched a copy of Johnson & Johnson's (J&J) inflammation-fighting Remicade in Germany on Thursday as the Swiss drugmaker aims to catch rival biosimilars that are already available in Europe's largest healthcare market.

Novartis's Sandoz generics unit in May won European approval for Zessly, known generically as infliximab. It has been ramping up production for six months, and Germany is the first European market where Novartis will sell its medicine to treat conditions such as arthritis and Crohn's disease.

After a Swiss newspaper reported on Thursday it could split off Sandoz, Novartis said it was "completely committed" to the business, where it is banking on biosimilars like Zessly to help it raise margins that are under pressure in the United States amid fierce competition for generic pills.

J&J's Remicade had some $7 billion in sales in 2016, though revenue is eroding as it loses market share to cheaper biosimilars - near copies of biological medicines that have lost patent protection - made by Pfizer and Celltrion, as well as Samsung Bioepis and Merck.

Despite being third to market with its Remicade copy, Novartis is hoping infliximab replicates the success of its copy of Roche's $7 billion-per-year blockbuster Rituxan: Novartis said its version, called Rixathon, has after 15 months a larger market share in Germany than the original medicine, as well as another biosimilar that also had a head start.

Novartis now has seven approved biosimilars in Europe, where it has enjoyed more success with its portfolio of near-copies than in the more sluggish U.S. market. There, a combination of regulatory hurdles, legal challenges and other obstacles have made for tougher going for biosimilars.

Novartis struck a deal allowing it to sell its copy of arthritis drug Humira in Europe starting in October, but must wait until 2023 to begin U.S. sales, as original maker AbbVie fiercely guards patents on the world's best-selling medicine.

And this month, Novartis abandoned plans to get U.S. approval for its version of Roche's Rituxan after the U.S. Food and Drug Administration demanded more information.

(Reporting by John Miller; Editing by Mark Potter)

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