Home » Economy » Testing by US authority – Novartis subsidiary Sandoz heads ahead with Biosimilar Rituximab | News

Testing by US authority – Novartis subsidiary Sandoz heads ahead with Biosimilar Rituximab | News

Tuesday, September 12th, 2017 | Economy

As the generics subsidiary Sandoz on Tuesday communicated, the US health authority FDA accepted the application for the biosimilar Rituximab. The authority will now examine it.
Sandoz has applied for approval of Rituximab as a biopharmaceutical product (Biologics License Application) in the same indications as Roche's reference agent Rituxan (rituximab). Rituxan is used in the treatment of various forms of blood cancer such as non-Hodgkin's lymphoma or chronic lymphocytic leukemia (CLL), as well as in the treatment of immunological diseases such as rheumatoid arthritis.
Sandoz is an extensive data package, according to the communication. It covers both analytical, pre-clinical and clinical data. These confirmed that the biosimilar in terms of safety, efficacy and quality was not in any way inferior to the reference material.
Approved in Europe
In Europe, Rituximab was already approved in June of this year. By now, five biosimilars have been approved by Sandoz worldwide, confirming the Novartis subsidiary's leading role in this field.
Especially in the US, the cost of cancer treatment worried both patients and their families as well as the health care system, Mark Levick, Global Head of Development, Biopharmaceuticals, is quoted in the announcement. Authorizing the biosimilar could make a decisive contribution to reducing costs, the manager adds. This in turn could release resources that could be put into other areas of the system.
Message flow stops
With the approval application, the Pharmac group continues a positive course. Only in the past few days did Novartis have been able to score points with good data from various studies.
On the stock market, the response is generally friendly. On Tuesday, the shares are gaining 0.6% against 10.30 am, which is roughly equivalent to the lead index SMI, which gained 0.65%.


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