The European Commission has approved a Novartis AG (ADR) (NYSE:NVS) novel treatment for inflammatory diseases such as rheumatoid arthritis psoriasis, Erelzi. The drug is a biosimilar to Amgen, Inc. (NASDAQ:AMGN) drug Enbrel.
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Developed by Novartis’s unit Sandoz, Erelzi is currently approved in the U.S. Its approval brings to five the number of Novartis biosimilars approved in Europe. The company plans to launch three more biosimilars as it continues to strengthen its oncology and immunology portfolio.
“Immunology is a priority for us and today’s approval of Erelzi, the second in this therapy area in as many weeks, clearly demonstrates our commitment to patients. This can also be seen in the progress we are making in our immunology pipeline with two recent file acceptances in Europe, “said Carol Lynch Sandoz global head
The Erelzi European approval follows the approval of Rixathon, a biosimilar version of Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) MabThera earlier this month. The company has also seen its Marketing Authorization Application for biosimilar versions of Humira and Remicade accepted by the European Medicines Agency.
Sandoz has filed a New Drug Application for GlaxoSmithKline plc. (ADR)(NYSE:GSK) asthma drug Advair Diskus. The FDA application is for the use of the generic drug in the treatment of asthma in patients aged above four years. The company also plans to market the drug as a maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Approval of the generic drug will put Novartis in direct competition with Mylan N.V. (NASDAQ:MYL).
Separately, Sandoz has signed an exclusive agreement with Ventura, for the development of a generic copy of brand lung therapy on sale in the U.S. Ventura is hoping to use the agreement to get a good a foothold of the $40 billion a year respiratory market.
Under the terms of the agreement, Ventura is to come up with the therapy’s formula and manufacture clinical batches for use in pilot studies. Sandoz on its part will head clinical development, manufacturing and commercialization should the drug achieve regulatory approval.
Novartis stock was down by 0.07% in Wednesday’s trading session to end the day at $85.25 a share.