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Top developments in biosimilars during 2012 Biosimilars/General | Posted 01/02/2013

Much has happened in the biosimilars’ industry over the last year.

Watson becomes Actavis Generics/News | Posted 01/02/2013

Watson Pharmaceuticals announced on 24 January 2013 that the company had officially adopted Actavis as its new global name under which it will now trade on the New York Stock Exchange.

HIV generics could significantly cut treatment costs Generics/Research | Posted 01/02/2013

The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients, according to a study published in the Annal...

Overview of research on G-CSF biosimilars in 2012 Biosimilars/Research | Posted 01/02/2013

Period: January to August 2012 A life-threatening complication for patients undergoing chemotherapy is febrile neutropenia, involving a loss of neutrophils (white blood cells) and fever [1]. G...

FDA gives details of generic drug user fees Policies & Legislation | Posted 01/02/2013

FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).

China’s SFDA to fast-track high-priority generics Guidelines | Posted 01/02/2013

China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation and allowing the fast-tr...

First generic versions of Duetact and Maxalt approved Generics/News | Posted 01/02/2013

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

Biosimilarity and interchangeability under the BPCI Act Biosimilars/Research | Posted 24/01/2013

In the US, the Biologics Price Competition and Innovation (BPCI) Act was signed into law on 23 March 2010, giving FDA the authority to approve biosimilars. FDA then issued guidelines for biosimilar...