Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug

Novartis has asked U.S. and European regulators to review its biosimilar of Biogen’s multiple sclerosis drug Tysabri, the company said Monday. If approved, the copycat version Tysabri could potentially launch as soon as next year.

Tysabri has become Biogen’s biggest-selling drug since generic competitors to its MS pill Tecfidera entered the market in 2020. New competition for Tysabri would further cut into revenue as the Massachusetts-based biotech struggles to recover from a foundering Alzheimer’s drug launch and sliding sales elsewhere.

Through the first six months of 2022, Biogen reported sales of just over $1 billion for Tysabri, compared with $808 million for Tecfidera and another $265 million for its successor Vumerity, which has fewer side effects.

Biogen’s final patents protecting Tysabri, which are based around methods of treatment, expire in 2027. Biogen CFO Michael McDonnell told investors on a conference call last week the company will seek to delay biosimilar launches in court, but acknowledged that “a biosimilar could launch upon approval in the U.S.”

One patent in the U.S. and a similar one in Europe are both due to expire on Feb. 25, 2023.

Speaking on Novartis’ earnings call last week, CEO Vas Narasimhan pointed to the Tysabri biosimilar as a product that could drive growth at the pharmaceutical firm’s Sandoz unit within the next few years.

Novartis is seeking approval of a formulation that must be injected intravenously. In the European Union, Biogen has won approval of a subcutaneous Tysabri, which could help it fight off competition from the Novartis rival. Like the intravenous version, however, it must still be administered by a healthcare professional.

The FDA previously rejected the subcutaneous version of Tecfidera. A Biogen spokesperson didn’t respond to an inquiry about its current status.

Tysabri is one of the most potent drugs to treat MS, reducing patient relapse rates by one-third and significantly delaying increases in disability in clinical testing. However, cases of a rare brain infection led to its withdrawal from market shortly after it launched in 2004.

When reintroduced a year later, patients and healthcare professionals were warned about the potential for that infection, particularly in individuals who have signs they were previously infected with a virus called JCV or are on treatment for more than two years.

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