Patients on Etanercept Now Have a Biosimilar Option for Their RA

A biosimilar to Amgen Inc’s Enbrel (etanercept) has been approved by the FDA. Developed by Sandoz, the generic wing of Novartis, Erelzi (etanercept-szzs) has been approved as an anti-inflammatory agent for use in rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.

Being a biosimilar, Erelzi is not clinically different from Enbrel, but the drugs are not interchangeable. There are currently no interchangeable biosimilars approved in the United States.

According to the press release announcing the approval, the FDA’s Arthritis Advisory Committee was unanimous in its decision on Enbrel. Novartis’ submission included analytical, nonclinical, and clinical data to substantiate that Erelzi is highly similar to the reference product. Sandoz conducted 4 comparative pharmacokinetic studies in 216 healthy volunteers and safety and efficacy studies in 531 patients diagnosed with chronic plaque psoriasis.

The product is currently under review by the European Medicines Agency.

“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," Carol Lynch, the global head of Biopharmaceuticals at Sandoz, said in a statement. “Sandoz is proud to have developed two of the three 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 Sandoz—Novartis partnership has been leading the way in the US biosimilar market. While biosimilar products developed by Sandoz have been in use in Europe for several years, Zarxio (filgrastim-sndz) was approved in the US only late last year. More recently, Novartis received a rejection letter from the FDA for its biosimilar to Neulesta.

Enbrel, which has been in the market since 1998, brought in $5.36 billion in sales for Amgen in 2015 and, even with a decline in sales with biosimilar competition, 2020 sales projections for the molecule hover around $5 billion. The company is fighting with Novartis to keep Erelzi out of the market using a patent protection argument.