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Agila Biotech and Pfenex make biosimilars deal
posted 17/05/2013
Agila Biotech, a subsidiary of India-based Strides Arcolab, and US-based biotech firm Pfenex announced on 16 April 2013 that... 
Sanofi starts biosimilar insulin trials
posted 14/05/2013
Pharma giant Sanofi confirmed in its 2013 Q1 business report that its biosimilar insulin projects (aspart and lispro) entered... 
Intas launches rituximab ‘similar biologic’ in India
posted 14/05/2013
India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regul... 
Sandoz applies for Japanese approval for biosimilar G-CSF
posted 06/05/2013
Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority... 
Biosimilars agreements for Hospira and mAbxience
posted 06/05/2013
In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013... |
Research
Development of biosimilars for rheumatology
posted 07/05/2013
In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biolo... 
Efficacy, extrapolation and interchangeability of biosimilars
posted 03/05/2013
Biosimilars have been available in Europe for more than seven years; despite this fact, physicians still have concerns about... 
Research on clinical trial issues for biosimilars
posted 03/05/2013
Period: September to December 2012 In order to demonstrate comparability between a biosimilar and its reference product,... 
Quality, similarity and safety of biosimilars
posted 03/05/2013
An abbreviated pathway for the approval of biosimilars was implemented in the EU in 2005. Despite biosimilars being available... 
Phase I/IIb trial of CT-P6 shows comparability to trastuzumab
posted 03/05/2013
Results of a phase I/IIb trial for South Korean biotechnology company Celltrion’s biosimilar candidate CT‑P6 were presented a... |
General
Biosimilars approved in Europe
posted 10/05/2013
Last update: 10 May 2013 In the EU, a legal framework for approving biosimilars was established in 2003. This frame... 
Biosimilars applications under review by EMA – 2013 Q1
posted 30/04/2013
Last update: 12 April 2013 The European Medicines Agency (EMA) is the body responsible for approval of biosimilars withi... 
Recall of anaemia drug highlights safety issues of NBCDs
posted 19/04/2013
US-based biotech firm Affymax announced on 24 February 2013 that it is recalling all lots of its red blood cell-stimulating m... 
Pharma companies sue EMA to block release of data
posted 19/04/2013
US-based biotech companies AbbVie and InterMune have both sued EMA in a bid to block publication of clinical trial data for t... 
US FDA defends biosimilar substitution
posted 19/04/2013
US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical A... |
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Biosimilars
General
- Biosimilars applications under review by EMA – 2013 Q1
- Recall of anaemia drug highlights safety issues of NBCDs
News
Research
Generics News Research General
- Sanofi fined for discouraging generic clopidogr...Generics/News | Posted 17/05/2013
- FDA rejects Endo petition to stop Opana ER gene...Generics/News | Posted 17/05/2013
- The biggest drug patent losses for 2013Generics/General | Posted 17/05/2013
- Innovation in the generics industryGenerics/Research | Posted 10/05/2013
Biosimilars News Research General
- Agila Biotech and Pfenex make biosimilars dealBiosimilars/News | Posted 17/05/2013
- Sanofi starts biosimilar insulin trialsBiosimilars/News | Posted 10/05/2013
- Intas launches rituximab ‘similar biologic’ in...Biosimilars/News | Posted 10/05/2013
- Biosimilars approved in EuropeBiosimilars/General | Posted 08/07/2011