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Trastuzumab ‘similar biologic’ to be launched in India Biosimilars/News | Posted 24/01/2014

India-based Biocon announced on 18 January 2013 that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market.

Switching to generic cyclosporine A after heart transplant safe Generics/Research | Posted 24/01/2014

Cyclosporine A is an immunosuppressant drug widely used in organ transplantation to prevent rejection. A study of switching between originator and generic drugs showed that the generic was well tol...

Brazil to designate medicamentos similares as interchangeable Policies & Legislation | Posted 24/01/2014

Medicamentos similares (similar medicines) may soon be substituted with the reference drug in Brazil, under the latest initiative launched by the country’s National Health Surveillance Agency [Agên...

Pfizer’s generics business up for grabs Pharma News | Posted 24/01/2014

In 2013, Pfizer, the world’s largest drugmaker, split its business into two brand-name drug units and a generics business. Now it seems the generics unit, or its ‘established products’ unit, is bei...

Immunogenicity testing in biosimilars Biosimilars/Research | Posted 24/01/2014

During a presentation given by Dr Kelly Colletti (Laboratory Sciences, USA) at an international conference on biowaivers and biosimilars, held in the US in September 2012, it was discussed whether...

FDA issues Ranbaxy with Form 483 for violations at Toansa plant Generics/News | Posted 24/01/2014

Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a For...

Alvotech invests US$250 million in biosimilars Biosimilars/News | Posted 24/01/2014

Iceland-based biopharmaceutical company Alvotech announced on 5 December 2013 that it would invest US$250 million to build a plant in Reykjavik for the development and manufacture of a portfolio of...

Biosimilar trastuzumab approved in Korea Biosimilars/News | Posted 17/01/2014

South Korean biotechnology company Celltrion announced on 15 January 2014 that it had received approval for its biosimilar monoclonal antibody Herzuma (trastuzumab) with the Korean Ministry of Food...