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WHO launches consultation on prequalification of biosimilars Biosimilars/General | Posted 15/09/2017

The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifying biosimilars in October 2017. The step is intended to make ‘some of the...

Sanofi receives tentative FDA approval for insulin lispro biosimilar Biosimilars/News | Posted 15/09/2017

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).

Positive phase III results for Amgen’s trastuzumab biosimilar Biosimilars/Research | Posted 15/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Fresenius Kabi acquires Merck KGaA’s biosimilars business Pharma News | Posted 15/09/2017

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 1 September 2017 that it had ‘successfully closed the acquisition of Merck KGa...

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis Biosimilars/Research | Posted 15/09/2017

Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is...

Generics applications under review by EMA – August 2017 Generics/General | Posted 15/09/2017

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...

Two trastuzumab biosimilars submitted to FDA Biosimilars/News | Posted 15/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.

Mylan launches three HIV generics in Canada Generics/News | Posted 15/09/2017

US generics giant Mylan Pharmaceuticals (Mylan) announced on 10 August 2017 that it had launched three generic HIV drugs in Canada, after having received final approval for the products from Health...