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Amneal and mAbxience make deal for bevacizumab biosimilar Pharma News | Posted 29/06/2018

US generics maker Amneal Pharmaceuticals (Amneal) and biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma (formerly the Chemo Group), announced on 23 May 2018 tha...

FDA issues draft guidance on biosimilar meetings Guidelines | Posted 29/06/2018

The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the developme...

DIA Biosimilars Conference 2018 Conferences | Posted 29/06/2018

DIA Biosimilars Conference 2018 22–23 October 2018 LondonUK

Terrapinn World Biosimilar Congress 2018 Conferences | Posted 29/06/2018

Terrapinn World Biosimilar Congress 2018 29–30 October 2018 Congress Centre BaselSwitzerland

Biosimilars and the role of regulatory authorities Biosimilars/Research | Posted 22/06/2018

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]:  (i)   manufacturing...

Celltrion resubmits biosimilar trastuzumab to FDA Biosimilars/News | Posted 22/06/2018

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food...

Developing biosimilars Reports | Posted 22/06/2018

Global pharmaceutical sales have grown 6.4% over the last five years to reach US$964 billion in 2017. Although the US still accounts for the major share of drug sales other markets are growing fast...

Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 Biosimilars/Research | Posted 22/06/2018

Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life...