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Novartis' (NVS) Sandoz Files for Enbrel Biosimilar in the U.S.

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NovartisNVS announced that 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.

Novartis had undertaken a series of actions to reorganize its portfolio in 2014 in order to focus on its core businesses of pharmaceuticals, eye care and generics. However, Novartis is expected to face headwinds this year in the form of generic competition for some products as well as negative currency movement.

On the other hand, the introduction of a biosimilar version of Enbrel, one of the key drugs of Amgen, will adversely impact its topline line which is already under pressure due to competition faced by key drugs Neupogen and Neulasta. Net sales of Enbrel were $4.4 billion in 2014 in the U.S.

Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Abbott Laboratories ABT , with a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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