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biosimilar - Articles and news items

First biosimilar mAb in oncology granted EU approval

Industry news / 23 February 2017 / Niamh Marriott, Digital Editor

The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU)…

Crohn’s disease

Celltrion Healthcare & Pfizer’s biosimilar shows positive results in Crohn’s disease study

Industry news / 20 February 2017 / Niamh Marriott, Digital Editor

Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial of CT-P13 (biosimilar infliximab) in Crohn’s disease.

Boehringer Ingelheim’s bevacizumab biosimilar demonstrates bioequivalence

Industry news / 21 November 2016 / Niamh Louise Marriott, Digital Content Producer

BI 695502, a bevacizumab biosimilar candidate to Avastin, is a monoclonal antibody that may slow or stop the growth of certain tumour types by preventing…

B is for Biosimilars

Blog / 15 November 2016 / Niamh Louise Marriott, Digital Content Producer

B is for Biosimilar – the next instalment of our daily pharmaceutical alphabet bringing you up to date with all the latest news and research on the subject of biosimilars.

FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

Industry news / 1 September 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis…

 

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