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Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe

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Novartis AGNVS announced that the European Commission (EC) has approved Erelzi - the biosimilar version of Amgen's AMGN Enbrel.

Erelzi is approved for use in all indications of the branded drug like rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis as well as juvenile idiopathic arthritis and pediatric plaque psoriasis.

The biosimilar is already approved in the U.S. We note that Sandoz is a global leader in biosimilars. With Erelzi's approval, Sandoz now has five biosimilars approved in Europe and plans to launch three more biosimilars of major oncology and immunology biologics across by 2020.

Earlier in the month, the EC approved Rixathon, a biosimilar version of Roche's RHHBY MabThera in Europe.

Last month, the European Medicines Agency (EMA) accepted the company's Marketing Authorization Applications for biosimilar versions of Humira (adalimumab) and Remicade (infliximab) for review. The generic unit had generated $10.1 billion sales in 2016.

Concurrently, Sandoz is also advancing its generic pipeline. The FDA recently accepted Sandoz's Abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline's GSK asthma drug, Advair Diskus. Sandoz gained additional expertise in the development of orally inhaled medicines through its 2010 acquisition of Oriel Therapeutics, Inc.

Upon approval, the generic drug will treat asthma in patients aged four years and older, as well as provide maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Hence, we expect investors to remain focused on Sandoz's ANDA approval. A potential approval will give Sandoz the edge over Mylan and boost its portfolio.

Novartis has outperformed the Zacks classified industry in the last six months. The stock has rallied 17.1% compared with the industry's gain of 13.8%.

Novartis has outperformed the Zacks classified industry in the last six months. The stock has rallied 17.1% compared with the Large Cap Pharmaceuticals industry's gain of 13.8%.

In 2016, Sandoz accounted for $10.1 billion, or 21%, of total net sales. Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis as it combats stiff generic competition for key drugs like Gleevec.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold).

You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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Roche Holding AG (RHHBY): Free Stock Analysis Report

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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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