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Novartis Filing for MabThera Biosimilar Accepted in the EU

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Novartis (NVS - Free Report) announced that the European Medicines Agency (EMA) has accepted its generic arm Sandoz’s Marketing Authorisation Application (MAA) for its proposed biosimilar of Roche's (RHHBY - Free Report) MabThera (rituximab).

We note that MabThera is approved for the treatment of non-Hodgkin's lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval of its biosimilar for the same indications as the reference product.

We are impressed by Sandoz’s efforts to broaden its biosimilars portfolio. MabThera is one of the leading oncology drugs across the world and Sandoz’s oncology portfolio already boasts two marketed products.

Sandoz currently markets three biosimilars – Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent; and Zarxio – in the U.S. Backed by its deep pipeline of biosimilars, the company plans to make 10 regulatory filings over the 2015–2017 time frame, of which six applications have already been submitted.

We note that the EMA had earlier accepted Sandoz’s MAA for its proposed biosimilar of Neulasta (pegfilgrastim).

Approval of new drugs, generics and biosimilars, along with the label expansion of existing ones, should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec of late.

Additionally, its oncology drugs are facing competition from immuno-oncology therapies. Moreover, the Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets.

Novartis currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT - Free Report) and Johnson & Johnson (JNJ - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy).

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