ZURICH (Reuters) – Novartis’s generics unit on Friday won a European panel’s recommendation for its biosimilar version of AbbVie’s Humira as the Swiss drugmaker aims to take a bite out of sales of the world’s best-selling medicine.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for marketing authorization of Novartis’s proposed biosimilar adalimumab. The European Commission nearly always follows the CHMP recommendation.

Novartis is among companies that have been working on a cheaper near-copy version of Humira, for autoimmune diseases including plaque psoriasis and Crohn’s disease, in hopes of grabbing a share of the $18 billion-per-year drug’s revenue. Humira’s primary patent expires in Europe in October.

“The introduction of our biosimilar adalimumab can help to expand access for those who need it most and give patients and doctors confidence in their chosen treatment option,” said Richard Francis, the head of Sandoz.

South Korea’s Samsung Bioepis, which also specializes in making cheaper copies of complex biotech drugs known as biosimilars, has also won approval for a Humira copy, as has Amgen.

Biosimilar copies of expensive biotech drugs are gaining momentum in Europe, which has been faster to adopt their use than the United States, and their potential to take business from companies making the original products is being monitored closely by investors.

AbbVie has been fighting to protect its cash cow in the United States.

Amgen last September reached a settlement with AbbVie that will delay the U.S. launch of Amgen’s cheaper biosimilar version of Humira until Jan. 31, 2023.


Reporting by John Miller; Editing by Michael Shields


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