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Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
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Novartis AG (NVS - Free Report) announced that the European Commission (EC) has approved Erelzi – the biosimilar version of Amgen’s (AMGN - Free Report) Enbrel.
Erelzi is approved for use in all indications of the branded drug like rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis as well as juvenile idiopathic arthritis and pediatric plaque psoriasis.
The biosimilar is already approved in the U.S. We note that Sandoz is a global leader in biosimilars. With Erelzi’s approval, Sandoz now has five biosimilars approved in Europe and plans to launch three more biosimilars of major oncology and immunology biologics across by 2020.
Earlier in the month, the EC approved Rixathon, a biosimilar version of Roche’s (RHHBY - Free Report) MabThera in Europe.
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.
Concurrently, Sandoz is also advancing its generic pipeline. The FDA recently accepted Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus. Sandoz gained 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). 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 17.1% compared with the Large Cap Pharmaceuticals industry’s gain of 13.8%.
In 2016, Sandoz accounted for $10.1 billion, or 21%, of total net sales. Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis as it combats stiff generic competition for key drugs like Gleevec.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold).
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Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
Novartis AG (NVS - Free Report) announced that the European Commission (EC) has approved Erelzi – the biosimilar version of Amgen’s (AMGN - Free Report) Enbrel.
Erelzi is approved for use in all indications of the branded drug like rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis as well as juvenile idiopathic arthritis and pediatric plaque psoriasis.
The biosimilar is already approved in the U.S. We note that Sandoz is a global leader in biosimilars. With Erelzi’s approval, Sandoz now has five biosimilars approved in Europe and plans to launch three more biosimilars of major oncology and immunology biologics across by 2020.
Earlier in the month, the EC approved Rixathon, a biosimilar version of Roche’s (RHHBY - Free Report) MabThera in Europe.
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.
Concurrently, Sandoz is also advancing its generic pipeline. The FDA recently accepted Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus. Sandoz gained 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). 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 17.1% compared with the Large Cap Pharmaceuticals industry’s gain of 13.8%.
In 2016, Sandoz accounted for $10.1 billion, or 21%, of total net sales. Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis as it combats 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.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation. See Them Free>>