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Draft revision of biosimilar low molecular weight heparin guideline

Published on 2013/04/22

EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs). The draft guideline ...

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China’s SFDA to fast-track high-priority generics

Published on 2013/04/19

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-tra...

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FDA gives details of generic drug user fees

Published on 2013/04/17

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). Legislation allowing FDA to ...

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Overview of research on G-CSF biosimilars in 2012

Published on 2013/04/15

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. Granulocyt...

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HIV generics could significantly cut treatment costs

Published on 2013/04/12

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 Annals ...

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Top developments in biosimilars during 2012

Published on 2013/04/10

Much has happened in the biosimilars’ industry over the last year. One of the most important developments during 2012 was the progress made in the US biosimilars pathway. In February 2012, FDA is...

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Mobilization of stem cells in healthy donors by G-CSF biosimilars shows comparable efficacy and safety to Neupogen

Published on 2013/04/08

Originator human recombinant granulocyte colony-stimulating factor (G-CSF) filgrastim has been widely used for the mobilization of CD34+ stem cells in healthy donors. However, there is limited experi...

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Overview of research on regulatory issues for generics in 2012

Published on 2013/04/05

Period: January to August 2012  Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of the generics industry. However, with ...

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Positive phase I data for infliximab biosimilar

Published on 2013/04/03

US-based Epirus Biopharmaceuticals (Epirus) announced on 4 January 2013 that its biosimilar infliximab candidate had ‘achieved bioequivalence’ to Remicade (infliximab) in a single dose comparator ...

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Generic antiepileptic drugs bioequivalent to brand-name drugs

Published on 2013/04/01

Results of a study, reported by Dr Ravi Juluru and colleagues at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on 30 November–4 December 2012, shows that generic slow...

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India issues more compulsory licences

Published on 2013/03/29

The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the drugs before the patents expire o...

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Top 10 most read GaBI Online articles in 2012

Published on 2013/03/27

2012 was a busy year with lots of developments in biosimilars from regulatory guidelines to comparability issues.  Biosimilars remain as the hot topic of the year for GaBI Online. So what were the m...

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