Biosimilars

Novartis wins another biosimilar round with an OK for its Rituxan copycat

Carol Lynch, Sandoz Global Head of Biosimilars

Novartis just racked up its fourth new biosimilar approval in Europe, this time gaining a thumbs up for its knockoff of Roche megablockbuster Rituxan.

The EC gave the pharma giant’s generics unit Sandoz a green light to sell Rixathon as a cheaper alternative to its branded rival at Roche. And it marks Roche’s second biosimilar competitor, following Celltrion’s win for Truxima, flagged through earlier this year.

Novartis now has the authority to sell its copycat for all indications approved for Rituxan, which earned a whopping $7.5 billion for Roche.

The news marks growing competition for Roche as it racks up some hits and misses on the development front. Just days ago it was forced to defend the closely watched results for a late-stage study combining Perjeta and Herceptin, which just barely managed to beat Herceptin alone in preventing a recurrence of breast cancer. And it’s been dealing with the stunning failure of its PD-L1 checkpoint Tecentriq in a pivotal trial, after it was approved for use. Roche needs to expand its newer franchise drugs to make way for the expected drop in revenue from flagship drugs like Rituxan as biosimilars start to eat into its market share.

“Today’s approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics. It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies” said Carol Lynch, the global head of biopharmaceuticals for Sandoz.


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RAPS Regulatory Convergence 2017