Novartis' (NVS) Sandoz Files for Enbrel Biosimilar in the U.S Print E-mail
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.
    
   



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!
 

Newsletter