As we predicted in yesterday’s post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. The FDA’s decision comes shortly after its Arthritis Advisory Committee voted unanimously in support of approving the biosimilar. FDA followed its draft naming guidance and assigned the biosimilar’s non-proprietary name using the reference product’s drug substance name followed by a nonsense four-letter suffix. Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, similar to Enbrel. However, Erelzi cannot be launched commercially until at least 6 months after Sandoz provides Amgen with the mandatory notice required under the law, which the Federal Circuit Court of Appeals has affirmed cannot be provided until after FDA approves the biosimilar application.
Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.