Biosimilars
News
FDA approves first biosimilar enoxaparin sodium
posted 13/08/2010
On 23 July 2010, Momenta Pharmaceuticals and Sandoz announced that they had received approval from the FDA for their biosimi... 
Cipla enters the biosimilars market
posted 02/07/2010
India-based generics’ manufacturer Cipla is paying US$65 million to buy a significant minority stake in two Asian biotech co... 
Hospira’s biosimilar filgrastim product Nivestim approved
posted 25/06/2010
On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for... 
Development of a new biosimilar filgrastim product (Zarzio)
posted 04/06/2010
Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially... 
Health Canada issues finalised guidance on biosimilars
posted 13/04/2010
Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEB... |
Research
How far does similarity go?
posted 25/08/2010
How much similarity does a biosimilar monoclonal antibody (mAb) have to show to its reference mAb? The European overarching... 
What clinical trials will be required for biosimilar mAbs?
posted 25/08/2010
The relevant European guideline states that if the reference medicinal product has more than one indication, the efficacy an... 
Technical challenges in defining mAbs
posted 25/08/2010
Monoclonal antibodies (mAbs) are highly complex molecules with secondary and tertiary structures. The drug substance (the mo... 
Phase I trial of a biosimilar erythropoietin
posted 25/08/2010
A Phase I clinical trial of Hospira’s biosimilar erythropoietin (EPO) in patients with anaemia associated with chronic renal... 
The biosimilars challenge
posted 30/07/2010
What are the challenges facing biosimilars? This was the question broached in a paper by Professor Håkan Mellstedt of the De... |
General
Global Industry Analysts: Global biosimilars market to exceed US$2 billion by 2015
posted 09/04/2010
On 24 March 2010, Global Industry Analysts (GIA) announced the release of a new report, entitled ‘Biosimilars: A Global Stra... 
Biosimilars mean competition for biologic brands
posted 09/04/2010
The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway...
Bionomics of biosimilars - Indian options for investors
posted 05/05/2010
As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for... 
Bionomics of biosimilars – EU and US markets not easy for India
posted 05/05/2010
As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for... 
Bionomics of biosimilars – Indian opportunities
posted 05/05/2010
As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for... |
