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Novartis Binocrit's Subcutaneous Formula Gets EC Approval

Novartis NVS announced that its generic arm, Sandoz, has received approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous administration of Binocrit (epoetin alfa) in its nephrology indication.

We note that Binocrit, a biosimilar version of Eprex, is approved to treat anemia in patients with chronic kidney failure and in adults receiving chemotherapy for certain types of cancer, as well as to reduce the requirement for blood transfusions.

The approval further broadens Sandoz’s biosimilar portfolio. We note that the approval of Zarxio (filgrastim) in the U.S. in 2015 has strengthened the company’s leadership position in biosimilars market.

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 period, of which five applications have already been submitted.

We note that the EMA has accepted Sandoz’s Marketing Authorisation Application for its proposed biosimilar of Amgen's AMGN Neulasta (pegfilgrastim) in the EU. The filing for Neulasta’s biosimilar in the EU was the fifth of the company’s 10 planned regulatory filings.

Approval of new drugs and 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 of late. Additionally, its oncology drugs are facing competition in the form of immuno-oncology therapies.

Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Novo Nordisk NVO and Johnson & Johnson JNJ. Both carry a Zacks Rank #2 (Buy).

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NOVO-NORDISK AS (NVO): Free Stock Analysis Report
 
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AMGEN INC (AMGN): Free Stock Analysis Report
 
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