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Novartis (NVS) Biosimilar of MabThera Approved in the EU

Zacks

Novartis AG NVS announced that its generic arm, Sandoz, has received European Commission (EC) approval for Rixathon, a biosimilar version of Roche’s RHHBY MabThera in Europe.

The biosimilar version has been approved for all the indications of the branded drug. Rixathon is approved for non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

We note that Sandoz is a global leader in biosimilars. With the approval of Rixathon, Sandoz now has four biosimilar drugs approved in Europe along with a deep pipeline. Sandoz plans to obtain the approval for four more biosimilars of major oncology and immunology biologics by 2020.

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.


Last week, the FDA accepted Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline’s GSK asthma drug, Advair Diskus.

We remind investors that Sandoz gaining 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).

Earlier in 2017, Mylan MYL received a complete response letter from the FDA regarding its ANDA for Advair Diskus.

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 12.6% compared with the Large Cap Pharmaceuticals industry’s gain of 11.4%.

Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. However, the company faces 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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