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Health Canada approves Inflectra biosimilar for extra indications posted 28/06/2016

US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had r...

Alvogen opening biosimilars plant in Iceland posted 17/06/2016

Iceland-based biopharmaceutical company Alvotech, a sister company of US generics company Alvogen, is set to open its state-o...

Rituximab biosimilar from Sandoz accepted for review by EMA posted 10/06/2016

Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab...

Samsung Bioepis infliximab biosimilar accepted for review by FDA posted 09/06/2016

Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administrat...

Positive phase III results for omalizumab copy biological posted 27/05/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had su...

 

Research

Doctors want more details in biosimilars labelling posted 04/07/2016

In the European Union (EU), labels (Summaries of Product Characteristics, SmPCs) for biosimilars and their reference products...

Mylan presents comparability data for trastuzumab biosimilar posted 04/07/2016

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American...

Real-world safety data for epoetin alfa biosimilar posted 04/07/2016

A 2-year post-marketing study of the epoetin alfa biosimilar Binocrit has found the biosimilar to be safe in daily clinical p...

Biosimilar rituximab in biological naïve rheumatoid arthritis patients posted 28/06/2016

Cost remains a major constraint in the use of originator biologicals in rheumatology in developing countries, paving the way...

Insulin biosimilar meets primary endpoint in phase III studies posted 24/06/2016

US pharma giant Merck announced on 13 June 2016 positive results from two phase III studies evaluating its insulin glargine b...

 

General

Subsequent entry biologics approved in Canada posted 24/06/2016

Last update: 24 June 2016 In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Th...

Biosimilars of eculizumab posted 23/06/2016

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxy...

Roche sues India’s drug regulator over Avastin ‘similar biologics’ posted 03/06/2016

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar...

Biosimilars of ranibizumab posted 03/06/2016

Last update: 3 June 2016Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bev...

Japan proving to be a favourable market for biosimilars posted 03/06/2016

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimila...