Tysabri® Biosim approved under REMS program

In June 2023, the US district court’s rejection in Biogen vs Sandoz’s Tysabri®’s patent infringement case where Biogen alleged an infringement of 28 Biogen patents (listed in US FDA Purple Book) by Sandoz and Polypharma, paved the way for Sandoz’s Tysabri® biosim approval (24/08/2023) – Tyruko (natalizumab-sztn).

As the listed patents (including US 9,493,567 and US 10,233,245) did not cover the actual product, Tysabri® – or its active ingredient – Natalizumab but were rather related to detecting antibodies, methods of assessing risk, and methods of manufacturing, Biogen failed to satisfy that it would suffer irreparable harm in the absence of an injunction or likely succeed on the merits. The product patent of Natalizumab expired 4 years ago and also lost BAAE exclusivity in the United States in 2016.

Tyruko is the first biosim to be approved in the United States for relapsing forms of Multiple Sclerosis. Since Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, in 2023, it is the 9^th drug to be approved under US FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. Other drugs approved in 2023 under REMS include:

1. Filspari (sparsentan), tablet – NDA #216403
2. Thalidomide – Shared System REMS
3. LUMRYZ (sodium oxybate extended-release), solution – NDA #214755
4. Brixadi (buprenorphine), injection – NDA #210136
5. PS-Mycophenolate – Shared System REMS
6. Vanflyta (quizartinib), tablet – NDA #216993
7. Elrexfio (elranatamab-bcmm), injection – BLA #761345
8. Hepzato (melphalan), injection – NDA #201848