Novartis AGNVS announced that the European Medicines Agency (EMA) has accepted the company's Marketing Authorization Applications for biosimilar versions of AbbVie's ABBV Humira (adalimumab) and Johnson & Johnson's JNJ Remicade (infliximab) for review.
Sandoz is seeking approval for use in all indications for which the drugs are approved. Sandoz currently markets three biosimilars - Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent; and Zarxio - in the U.S. In addition, Sandoz has a strong pipeline of biosimilars including Roche's RHHBY Rituxan.
In Apr 2017, the CHMP gave positive opinion on biosimilar versions of Rituxan and Enbrel. Hence, Novartis is on track to launch five biosimilars of major oncology and immunology biologics by 2020.
Concurrently, Novartis shed light on its long-term plans as well. The company expects the next growth phase to begin in 2018 driven by Cosentyx (in all three indications psoriasis, psoriatic arthritis and ankylosing spondylitis (AS)) Entresto, and Kisqali and a deep pipeline with candidates like CTL019, BAF312, AMG 334, RTH258. We note that Cosentyx attained the blockbuster status in 2016.
The company is, however, facing significant pricing pressures in the U.S. in its Sandoz division and the impact of the delayed launch of Glatopa 40mg are likely to impact the second-quarter results.
Meanwhile, Novartis is conducting a strategic review of the Alcon Division and exploring all options to maximize value for shareholders. The company stated that the review is on track and will provide a status update for the same toward the end of 2017.
So far in the year, Novartis has outperformed the Zacks classified industry. The stock has rallied 12.3% compared with the Large Cap Pharmaceuticals industry's gain of 9%.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here .
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