Enbrel Biosimilar Gains FDA Approval

The FDA on Tuesday approved Sandoz’s Erelzi (etanercept-szzs), a biosimilar of Amgen’s Enbrel (etanercept), for all indications of the branded drug.

The biosimilar has indications for rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.

“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system” said Carol Lynch, global head Biopharmaceuticals for Sandoz. “Sandoz is proud to have developed 2 of the 3 biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible".

The approval follows a unanimous vote by the FDA’s Arthritis Advisory Committee to recommend use in all indications, according a press release from Novartis. Clinical studies included comparative pharmacokinetic studies in healthy patients, and a similarity study conducted in patients with chronic plaque psoriasis.

The FDA reviewed structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other safety and efficacy data, according to the FDA.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

Severe adverse events associated with Erelzi are infections, neurologic events, heart failure, and hematologic events. Infections and injection site reactions are among the most common adverse events.

The FDA also reports that lymphoma and other cancers have been reported in young patients using tumor necrosis factor blockers, such as etanercept products, causing a Boxed Warning to be issued. Another Boxed Warning alerts patients about the increased risk for serious infections that can lead to death.

The biosimilar application is currently under review by the European Medicines Agency. Erelzi is Sandoz’ second biosimilar to receive FDA-approval. They plan to launch 5 biosimilars by 2020 for Humira, Neulasta, Remicade, and Rituxan, according to a previous press release from Sandoz.

Through biosimilars, Sandoz predicts increased patient access and global healthcare savings.