|Novartis' (NVS) Sandoz Files for Enbrel Biosimilar in the U.S|
|By Zacks Equity Research|
|Monday, 05 October 2015 19:02|
Novartis NVS (NYSE: NVS) announced the FDA has accepted its generic arm, Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s AMGN blockbuster drug, Enbrel (etanercept).
The application was approved under the 351 (k) pathway. Enbrel, a tumor necrosis factor alpha (TNF-alpha) inhibitor, is approved in the U.S. for moderately to severely active rheumatoid arthritis (RA), chronic moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis.
Sandoz is seeking approval for all approved indications. We note that Sandoz continues to advance its portfolio of biosimilars. Last month, the division launched Zarxio in the U.S., the biosimilar version of Amgen’s another blockbuster drug, Neupogen. Zarxio became the first FDA-approved biosimilar to be launched in the country.
In Jun 2015, Sandoz launched Glatopa, the first generic version of Teva’s multiple sclerosis drug, Copaxone 20 mg (once daily). Sandoz has a strong pipeline of biosimilars including the biosimilar versions of Roche’s RHHBY Rituxan. Sandoz plans to make 10 regulatory submissions in the next three years.