Novartis NVS announced that the European Medicines Agency (EMA) has accepted its generic arm Sandoz’s Marketing Authorisation Application (MAA) for a biosimilar version of Pfizer Inc.’s (PFE) blockbuster drug, Enbrel.
While Amgen Inc. AMGN markets the drug in the U.S., Pfizer commercializes the drug outside the U.S. and Canada. We note that Enbrel is approved for several indications including the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis and plaque psoriasis among others.
Sandoz is seeking approval for all of these indications and has submitted results from two pivotal studies that demonstrate the equivalence of the biosimilar version to the reference product.
We remind investors that the FDA had accepted Sandoz’s Biologics License Application (BLA) for the biosimilar version of Enbrel in Oct 2015.
We are positive on Sandoz’s efforts to broaden its portfolio of biosimilars. In Sep 2015, Sandoz launched Zarxio in the U.S., the biosimilar version of Amgen’s blockbuster drug, Neupogen. Zarxio became the first FDA-approved biosimilar to be launched in the country.
In Nov 2015, the FDA accepted Sandoz’s BLA for its proposed biosimilar version of Amgen’s Neulasta.
The filing for Enbrel’s biosimilar in the EU is the third of the company’s 10 planned regulatory filings over the next three years.
A potential approval for its biosimilars will help the company somewhat offset the impact of loss of revenues from its other drugs that are facing generic competition, such as Diovan.
Last month, Biogen Inc.’s BIIB joint venture with Samsung Biologics, Samsung Bioepis, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use for its MAA for its proposed biosimilar version (Benepali) of Enbrel.
Novartis currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the healthcare sector is AstraZeneca PLC AZN, currently sporting a Zacks Rank #1 (Strong Buy).
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