Roche Launches Legal Battle Against Biogen’s Imitative Biosimilar of Blockbuster Arthritis Drug

Roche Launches Legal Battle Against Biogen’s Imitative Biosimilar of Blockbuster Arthritis Drug

July 14, 2023  – Roche (ROG.S) and its subsidiary powerhouses have taken a decisive step by initiating legal proceedings against biotech frontrunner Biogen (BIIB.O) in the federal court of Massachusetts. Their grievance centers around Biogen’s audacious attempt to replicate Roche’s highly successful drug for rheumatoid arthritis, Actemra, with a biosimilar version, which Roche claims flagrantly infringes upon their precious patents.

Roche, Genentech and Chugai Pharmaceutical fervently presented their case before the court, asserting that Biogen’s biosimilar venture illicitly encroaches upon the patents related to the intricate production and utilization of their remarkable biologic concoction. When approached for comment on the matter, a representative for Biogen maintained a discreet silence, citing ongoing litigation as the cause for their reticence. Meanwhile, Roche’s spokesperson opted not to divulge any details about the case but reiterated the company’s belief that fostering competition through biosimilars is vital in ensuring the financial viability of healthcare systems while simultaneously carving out space for groundbreaking innovations.

Actemra, a pharmaceutical marvel pioneered by Roche and approved by the U.S. Food and Drug Administration in 2010 for treating rheumatoid arthritis, has achieved resounding success and subsequently obtained approval for diverse applications, including the treatment of COVID-19 patients in hospital settings. Last year, Roche, headquartered in Switzerland, reported a staggering revenue of over 2.7 billion Swiss francs, which equates to approximately $3.1 billion based on current exchange rates, generated through global Actemra sales. However, due to decreased demand for the drug as a COVID-19 treatment, this figure experienced a downturn of 22% compared to the previous year.

Unlike traditional small-molecule drugs that can be easily replicated as generics, biosimilars present a far more intricate challenge. These bioengineered medications, crafted from living cells, defy exact duplication. In December, the FDA accepted Biogen’s application to review their proposed biosimilar, adding fuel to Roche’s fire.

In their legal action, Roche contends that Biogen, headquartered in Cambridge, Massachusetts, failed to furnish comprehensive information during the biosimilar approval process, a crucial requirement for determining whether their enterprise impinges upon Roche’s patent rights linked to the intricate manufacturing processes employed in their formulation. Despite being coerced into evaluating Biogen’s potential infringement based on inadequate information, Roche steadfastly maintains that the violations committed by their adversary remain apparent.

The case, identified as Genentech Inc v. Biogen MA Inc, is set to unfold in the U.S. District Court for the District of Massachusetts, bearing the number 1:23-cv-11573.