On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi (collectively “defendants”) (DNJ No. 23-cv-22485). The plaintiffs allege that the defendants infringe or intend to infringe fifteen patents related to the biologic rituximab, which the plaintiffs sell as Rituxan.
Rituximab is an anti-CD20 monoclonal antibody used for the treatment of various cancers and autoimmune diseases, including leukemia, lymphoma, and rheumatoid arthritis.[1] Rituxan (rituximab) was first FDA-approved in 1997.[2] There are currently three FDA-approved rituximab biosimilars on the market: Celltrion’s Truxima (approved in 2018), Pfizer’s Ruxience (approved in 2019), and Amgen’s Riabni (approved in 2020).[3] Dr. Reddy’s rituximab biosimilar is already approved and marketed as Reditux and Tidecron in India and several Latin American countries.[4]
This is not the first BPCIA case the plaintiffs have filed over rituximab; complaints were filed against Sandoz in December 2017 and Celltrion in January 2018. Both complaints were also filed in D.N.J., and both cases were settled by the end of 2018. However, this is the first complaint filed since other rituximab biosimilars entered the market.
[1] https://www.ncbi.nlm.nih.gov/books/NBK564374/
[2] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103705
[3] https://www.goodrx.com/rituximab/biosimilars
[4] https://www.gabionline.net/biosimilars/general/Biosimilars-of-rituximab