US: Sandoz sees route to market with Enbrel biosimilar blocked for eight more years
Erelzi (etanercept-szzs) was approved by the FDA in August 2016. However, Sandoz has been unable to launch the drug in the US due to the patent litigation from Amgen covering the active ingredient in Enbrel.
The US Court of Appeals for the Federal District in July 2020 ruled against Sandoz, upholding a prior ruling from the New Jersey District Court, which declared Sandoz had failed to demonstrate that the Amgen patents were invalid.
Keren Haruvi, president of Sandoz US said the decision, announced yesterday [May 17], means Erelzi will not be available to US patients with autoimmune and inflammatory diseases until 2029.
Estimates suggest that a biosimilar etanercept could have saved the US healthcare system around US$1bn per year, said Sandoz.
“Nonetheless, we remain committed to providing important treatment options for patients affected by these diseases,” said Haruvi.
Enbrel generated US$4.9bn in revenues for Amgen in 2020, some 4% lower than its earnings the year prior for that drug - US$5.2bn.
Samsung Bioepis received approval for its etanercept biosimilar (Eticovo) in April 2019, but patent litigation is also preventing that drug from being launched in the US.
There are three etanercept biosimilars approved in the EU; the first of those approved, Benepali, was launched in January 2016.
Approved indications
Sandoz was the first company to receive approval from the US Food and Drug Administration (FDA) for a biosimilar etanercept and the first company to launch a biosimilar medicine in the US; Erelzi is approved by the US regulatory agency for adult rheumatoid arthritis (RA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO).
The biosimilar has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study.
The drug is also currently being studied in a real world setting through COMPACT, a global non-interventional study conducted in countries such as Austria, Canada, France, Germany, Italy, Poland, Spain, Switzerland and the UK, said Sandoz.
