Court ruling hinders patient access to new biosimilar

Written by Ilana Landau, Editor

A District Court of New Jersey (NJ, USA) rule has prevented the marketing of a new, anti-inflammatory biosimilar agent that could offer an affordable treatment for patients with chronic inflammatory diseases.

The District Court of New Jersey (USA) has ruled against Sandoz (Holzkirchen, Germany) — a Novartis division biosimilar manufacturer — in patent litigation. The ruling prevents Sandoz marketing their chronic autoimmune and inflammatory therapeutic agent Erelzi® (etanercept-szzs) — a biosimilar of the currently available Enbrel® (etanercept; Amgen, CA, USA).

Biosimilars are near identical agents of biologic products marketed by an original manufacturer that generate competition between drug producers. In instances of high demand, competition is the single most efficient means of driving down drug prices and increasing in-need patients’ access to therapies. Biosimilar agents offer matched safety and efficacy to original biologics.

Robin Dore, Clinical Professor of Medicine at the David Geffen School of Medicine (CA, USA), explained: “Biologics are life-changing medicines, but can be costly, creating significant disparities in patient access that need to be challenged…Biosimilars help increase patient access to these potentially life-saving medicines and real-world experience affirms that switching between a biosimilar and a reference medicine is safe and effective.”

Sandoz is the first biopharmaceutical manufacturing company to have received FDA approval for the development of an etanercept — an inhibitor of the inflammatory mediator TNFα — biosimilar.

Erlezi has been approved for safe and effective use in patients for over 3 years; however, its marketing has been stilted by the ongoing patent dispute with Amgen.

Carol Lynch, President of Sandoz USA, commented: “Sandoz respectfully disagrees with the Court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases.”

Lynch explained: “Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible.”