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Novartis' Enbrel Biosimilar Gets FDA Panel Recommendation

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Novartis AG (NVS - Free Report) announced that the FDA’s Arthritis Advisory Committee has recommended an approval of the company’s proposed biosimilar of Amgen’s (AMGN - Free Report) blockbuster drug, Enbrel (etanercept).

The committee voted unanimously (20-0) for an approval of a biosimilar version of Enbrel for all five indications of the reference product. The indications include rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

Novartis’ generic arm, Sandoz, presented data from a global development program comprising analytical, pre-clinical and clinical studies, which demonstrated biosimilarity to the reference product. These studies included four comparative pharmacokinetic (PK) studies and a confirmatory efficacy and safety similarity study in patients with chronic PsO.

We note that the FDA generally takes the recommendation of its advisory committees into account when it reviews the applications, but is not bound to follow it.

Meanwhile, the European Medicines Agency (EMA) accepted Sandoz’s Marketing Authorisation Application (MAA) in Dec 2015 for its biosimilar version of Enbrel, which sought an approval of the product for the same indications as the reference product.

We are encouraged by the company’s efforts to develop its biosimilars portfolio. Sandoz currently markets three biosimilars – Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent; and Zarxio – in the U.S. Sandoz also has a deep pipeline with several biosimilars in late-stage development, including assets in the fields of immunology and oncology.

We believe investors should watch out for an approval of new drugs and label expansion of existing ones at Novartis as the company has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec.

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

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Roche Holdings (RHHBY - Free Report) and Johnson & Johnson (JNJ - Free Report) . All three carry a Zacks Rank #2 (Buy).

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