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FDA approves bevacizumab biosimilar Mvasi Biosimilars/News | Posted 22/09/2017

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Positive phase III results for Pfizer’s trastuzumab biosimilar Biosimilars/Research | Posted 22/09/2017

Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuzumab biosimilar. Pfizer says that ‘data from the REFLECTIONS B327-02 stu...

Regulatory pathways for approval of biological products in Brazil Reports | Posted 22/09/2017

Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologic...

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10 Biosimilars/Research | Posted 22/09/2017

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituxi...

Second etanercept biosimilar approved in Canada Biosimilars/News | Posted 22/09/2017

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

FDA forms working group to increase generics competition Generics/General | Posted 22/09/2017

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.

Biosimilars applications under review by EMA – August 2017 Biosimilars/General | Posted 22/09/2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Indivior to appeal US ruling on opioid addiction patent Generics/News | Posted 22/09/2017

UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not...