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US FDA defends biosimilar substitution Biosimilars/General | Posted 01/03/2013

US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA...

India supplies 20% of generic drugs worldwide Reports | Posted 01/03/2013

Every fifth tablet, capsule and injectable generic drug being used in the world is manufactured in India, according to India’s Health Minister Ghulam Nabi Azad.

MS patient dies from immunogenicity to biological drug Biosimilars/Research | Posted 01/03/2013

A Swedish woman diagnosed with multiple sclerosis (MS) appears to have died after developing unwanted immunogenicity toward the biological drug Tysabri (natalizumab), according to a report in the j...

Mylan and Biocon to partner on insulin products Biosimilars/News | Posted 01/03/2013

Generics giant Mylan announced on 13 February 2013 that it had entered into an agreement with India-based Biocon to develop and market Biocon’s biosimilar versions of three insulin analogue products.

Ranbaxy restarts generic atorvastatin production Generics/News | Posted 01/03/2013

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamin...

Egypt issues draft guidelines for biosimilars Guidelines | Posted 01/03/2013

The Egyptian Drug Authority (EDA) announced on 20 January 2013 that a draft guideline for the registration of biosimilars in Egypt had been released by the Central Administration for Pharmaceutical...

Oncobiologics and Viropro make biosimilar deal Biosimilars/News | Posted 01/03/2013

US-based Oncobiologics and monoclonal antibody developer Viropro announced on 25 February 2013 that they had signed a biosimilar collaboration agreement between the two companies.

Biologicals in EU to be identified by brand names Policies & Legislation | Posted 22/02/2013

The European Commission has issued a directive, which requires biological products to be identified by brand name and not by international nonproprietary name (INN).