USA — Roche, the Swiss pharmaceutical company, has filed a lawsuit in US federal court alleging that Biogen’s proposed biosimilar, BIIB800, which references Roche’s arthritis drug Actemra (tocilizumab), infringes multiple patents.
Roche’s subsidiaries, Genentech and Chugai Pharmaceutical, are also parties to the complaint. The lawsuit comes after the US Food and Drug Administration (FDA) accepted Biogen’s biologics license application (BLA) to review BIIB800 late last year.
While a Roche spokesperson declined to discuss the specifics of the case, the company emphasized its belief in the importance of biosimilar competition for supporting the financial sustainability of healthcare systems and fostering innovation.
In the complaint filed at the US District Court for the District of Massachusetts, Roche and its subsidiaries claim that BIIB800 would infringe patents related to the manufacturing and usage of Actemra.
The monoclonal antibody drug is designed to inhibit the IL-6 receptor. Roche alleges that Biogen did not provide sufficient information during the BLA process, making it challenging to determine whether BIIB800 infringes Roche’s patents.
Despite the incomplete information, Roche states that it has reason to believe that BIIB800 has or will infringe 20 US patents owned by the plaintiffs in the case, with none of the patents having expired yet.
In response to the alleged patent infringement, Roche is seeking a jury trial and requesting an injunction against the production and sale of Biogen’s biosimilar.
Additionally, Roche is pursuing potential damages for any lost profits resulting from the alleged infringement.
Biogen, the defendant in the case, has chosen not to comment on the ongoing litigation.
Biogen announced the FDA’s acceptance of its Actemra biosimilar application in December, while the European Medicines Agency accepted Biogen’s marketing application for the drug in September.
Biogen is collaborating with Bio-Thera Solutions for the development, production, and marketing of its Actemra biosimilar in all countries except China.
Roche, in its 2022 annual report, suggested that the first biosimilar versions of Actemra could enter the European and US markets in the second half of 2023.
Known as RoActemra in Europe, the drug’s basic patents have expired in both the US and the European Union.
Apart from Biogen, other companies such as Fresenius Kabi and Celltrion are also working on late-stage Actemra biosimilars.
Fresenius reported that the FDA accepted its biosimilar application in August 2022, positioning it at the forefront of Actemra biosimilar development. Celltrion has submitted its Phase 3 Actemra biosimilar, CT-P47, to the FDA.
Actemra has experienced increased sales due to its use in treating COVID-19 towards the end of its patent exclusivity period.
Chinese officials recommended Actemra for patients with an uncontrolled immune response to the coronavirus, leading to its inclusion in Chinese COVID-19 treatment guidelines in March 2020.
Actemra received emergency use authorization from the FDA to treat certain severe COVID-19 patients in June 2021, which was later followed by full FDA approval in 2022.
Initially approved by the FDA in 2010 for the treatment of rheumatoid arthritis in adults, Actemra has since gained approval for other conditions such as systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
It is also approved for giant cell arteritis, CAR-T cell-induced cytokine release syndrome, systemic sclerosis-associated interstitial lung disease, and COVID-19 in hospitalized patients.
Roche reported global Actemra sales of over CHF 2.7 billion (US$3.1 billion) in the previous year. However, sales decreased by 22% compared to 2021 due to decreased demand for the drug as a treatment for COVID-19.
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