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EU publishes consensus report on biosimilars Reports | Posted 03/05/2013

The European Commission’s (EC’s) Enterprise and Industry Directorate-General has published a new report providing comprehensive information on the concept of biosimilars.

Sandoz applies for Japanese approval for biosimilar G-CSF Biosimilars/News | Posted 03/05/2013

Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing auth...

Indian FDA wants to increase use of generics Generics/General | Posted 03/05/2013

The Commissioner of Indian Food and Drug Administration (FDA) has denied allegations by physicians and pharmacists in India that the bioavailability of generic drugs is doubtful.

Biosimilars agreements for Hospira and mAbxience Biosimilars/News | Posted 03/05/2013

In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimi...

Actavis makes agreement for generic abuse-deterrent oxycodone Generics/News | Posted 03/05/2013

US generics maker Actavis (formerly Watson) announced on 26 April 2013 that it had reached an agreement with Purdue Pharma (Purdue) to settle all outstanding patent litigation related to Actavis’ g...

Argentinian guidelines for similar biological medicines Guidelines | Posted 03/05/2013

The regulatory body for approval of medicines in Argentina is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices...

Quality of generics in South Africa Generics/Research | Posted 29/04/2013

A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].

Hospira marks five years of biosimilars Biosimilars/News | Posted 29/04/2013

Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2...