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FDA accepts license application for Novartis' rituximab biosimilar

Sandoz, Novartis’ generics and biosimilars division, has revealed that the FDA has accepted its Biologics License Application (BLA) for a proposed biosimilar version of Roche and Genentech’s Rituxan (rituximab), a treatment for blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as rheumatoid arthritis (RA).

Investigational antibody boosts chemotherapy's cancer-killing potential

A proof-of-concept study conducted at the Duke Cancer Institute (DCI) in North Carolina has shown that an investigational antibody has the ability to boost the cancer-killing effects of chemotherapy rituximab in those who have a natural resistance to it.

UK launch of two Novartis biosimilars could cut NHS costs

Sandoz, a division of Swiss pharma giant Novartis, has revealed that two of its biosimilars – Rixathon (biosimilar rituximab) and Erelzi (biosimilar etanercept) – are now available in the UK for use in Europe. Both new medicines have been proven to be non-inferior to their reference products, MabThera and Enbrel, respectively.

Sandoz biosimilars as safe and efficacious as originators, says early trials data

Sandoz, a division of Novartis, has presented data at the Annual European Congress of Rheumatology (EULAR 2016) demonstrating the safety and efficacy of their biosimilar versions of autoimmune disease treatments, Enbrel (etanercept) and Mabthera (rituximab).

In both early stage studies, the Sandoz biosimilars achieved pharmacokinetic bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator.

Novartis challenges Roche with MabThera biosimilar

Novartis' Swiss headquarters
Novartis unveiled a new business strategy last year that will increase its involvement with generics and biosimilars to provide some insulation from traditional patent cycles

Novartis’ generics unit Sandoz has begun mid-stage trials of a biosimilar version of Roche’s blockbuster drug MabThera.

The phase II trial is looking at patients with rheumatoid arthritis aims to ensure biosimilarity with MabThera (rituximab), a monoclonal antibody currently indicated to treat rheumatoid arthritis and non-Hodgkin’s lymphoma.

NICE recommends MabThera for non-Hodgkin's lymphoma

Roche's MabThera

NICE has given a preliminary green-light to Roche’s MabThera for use as a maintenance therapy for non-Hodgkin’s lymphoma.

The Institute’s draft guidance recommends MabThera (rituximab) as a first-line maintenance treatment for certain patients with advanced follicular non-Hodgkin's lymphoma.

ASCO cancer conference opens

ASCO is a key date in the industry's calendar. Photo credit: ASCO

One of the most important dates in the pharmaceutical industry’s calendar, the ASCO cancer conference begins today.

The American Society of Clinical Oncology meeting is the foremost congress for pharma and academic researchers to announce data from what they hope are ‘landmark’ clinical trials in cancer.

The five day conference is huge in scale – attracting around 30,000 delegates and abstracts from 4,000 studies posted on the ASCO website.

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