FDA accepts Sandoz submission for biosimilar to Enbrel candidate

Sandoz, a company owned by Novartis, announced the FDA has accepted its Biologics License Application for its proposed biosimilar to Enbrel and is seeking approval for all of its indicated diseases, including rheumatoid arthritis and psoriasis, according to a company press release.

Like Enbrel (etanercept, Amgen), the biosimilar to etanercept is an anti-tumor necrosis factor-alpha (anti-TNF) agent. The submission follows a pharmacokinetic clinical trial in healthy volunteers and a safety and efficacy study for the treatment of patients with plaque psoriasis.

“Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines,” Mark McCamish, MD, PhD, head of global biopharmaceutical and oncology injectables development at Sandoz said in the release. “We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”

Sandoz launched the first biosimilar to attain U.S. approval by the FDA, Zarxio (filgrastim-sndz), indicated for the treatment of certain types of cancer and other conditions in March. Last month, the U.S. Senate Subcommittee on Primary Health and Retirement Security held a hearing with Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA about biosimilar treatments and the current state of guidance documents.

Reference : http://www.us.sandoz.com.