Back to top

Image: Bigstock

Novartis Gets Positive CHMP Opinion on Biosimilar Remicade

Read MoreHide Full Article

Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion for the marketing authorization of the proposed biosimilar of Johnson & Johnson’s (JNJ - Free Report) Remicade (infliximab).

The CHMP recommended the approval of the biosimilar for all the indications of the branded drug across gastroenterology, rheumatology and dermatology. We note that Remicade is approved to treat Crohn's Disease in adults and children, ulcerative colitis, rheumatoid arthritis and psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.

The positive opinion was based on a comprehensive data package that is expected to confirm the biosimilarity of infliximab to the original drug with analytical, preclinical and clinical data matching across quality, efficacy and safety.

Earlier, the phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of proposed Sandoz biosimilar infliximab to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at week 14.

 

 

Novartis’ shares have declined 4.5% over a year, compared with the industry’s fall of 3.7%.

Novartis generic arm, Sandoz, is a leader in biosimilars with five marketed products. The marketed biosimilars include — Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent used to treat anemia; filgrastim for neutropenia under the brand names Zarzio outside the United States and Zarxio in the United States; Rixathon (biosimilar rituximab), approved in Europe in 2017 to treat blood cancers and immunological diseases (also approved in the EU as Riximyo under a duplicate marketing authorization); and Erelzi (biosimilar etanercept), approved in Europe in 2017 to treat multiple inflammatory diseases.  The FDA also approved biosimilar Erelzi in 2016. However, the launch is pending in the United States due to an ongoing litigation with Amgen (AMGN - Free Report) .

EMA is due to review CHMP’s opinion.  We note that Sandoz acquired the biosimilar of infliximab from Pfizer (PFE - Free Report) in February 2016 for the 28 EU countries plus Norway, Iceland and Liechtenstein that form the EEA. Per the terms, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA.

Meanwhile, Sandoz has quite a number of biosimilars in its pipeline. A tentative approval will further boost the company’s generic division. The company has also filed for approval of a biosimilar of adalimumab and pegfilgrastim in the EU.

Apart froma strong generic portfolio, Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu, and Kisqali. The recent approval of Kymriah for acute lymphoblastic leukemia is a major boost for Novartis given the potential in the CAR-T therapy space.

Zacks Rank

Novartis carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

5 Medical Stocks to Buy Now

Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.

Click here to see the 5 stocks >>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Novartis AG (NVS) - free report >>

Johnson & Johnson (JNJ) - free report >>

Pfizer Inc. (PFE) - free report >>

Amgen Inc. (AMGN) - free report >>