FDA approves Novartis Enbrel biosimilar
pharmafile | August 31, 2016 | News story | Research and Development, Sales and Marketing | Enbrel, FDA, Novartis, Sandoz, biosimilar, erzeli
Novartis, through its Sandoz division, has announced that the FDA has approved Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug Enbrel.
It has been approved by the US regulator for all indications on the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. It is the second Sandoz biosimilar to receive FDA approval after Zarxio, which is a biosimilar of Amgen’s Neupogen (filgrastim).
An FDA advisory committee had recommended the proposed biosimilar in a unanimous 20-0 vote. The committee based its decision on data provided by Sandoz demonstrating pharmacokinetic data over four comparative studies.
Carol Lynch, global head of biopharmaceuticals at Sandoz, says: “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. 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 European Medicines Agency is currently reviewing an application for Erelzi, after accepting the application in late 2015. Novartis already has already made six filings for biosimilar versions of major oncology and immunology biologics, with a total of 11 planned for the three year period (2015-2017).
Sean Murray
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