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Darbepoetin alfa ‘similar biologic’ launched in India posted 28/08/2015

India-based Hetero, one of the largest manufacturers and suppliers of active pharmaceutical ingredients (APIs) to the Indian...

Rituximab similar biologic launched in India posted 28/08/2015

India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biol...

Non-originator infliximab approved in Russia posted 28/08/2015

South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsi...

Biosimilar infliximab offered to French hospitals at 45% discount posted 28/08/2015

A major French hospital group has chosen biosimilar infliximab to treat its patients with rheumatoid arthritis, Crohn’s disea...

Biosimilars licensing agreements for AMP and Formycon posted 28/08/2015

German biosimilars companies AMP Biosimilars (AMP) and Formycon have both made out-licensing agreements for their candidate b...

 

Research

Non-originator bevacizumab candidate non-inferior to Avastin posted 31/08/2015

Results of a phase III clinical study of Biocad’s non-originator bevacizumab candidate BCD-021 demonstrated ‘equivalence’ com...

Positive phase III results for candidate etanercept and infliximab biosimilars posted 23/08/2015

Results of pivotal phase III clinical studies of candidate etanercept biosimilar SB4 and candidate infliximab biosimilar SB2...

Overcoming hurdles to biosimilars cost savings in the US posted 23/08/2015

The US approved its first biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [1]. But how can the country overcome hurdles...

Phase I results for candidate adalimumab, etanercept and infliximab biosimilars posted 23/08/2015

Results of phase I clinical studies of candidate adalimumab biosimilar SB5, etanercept biosimilar SB4 and infliximab biosimil...

Safety of filgrastim biosimilars following stem-cell transplantation posted 23/08/2015

The safety of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars was compared with that of the originator,...

 

General

Biosimilars approved in Australia posted 28/08/2015

Last update: 28 August 2015In Australia, the legal framework for approving medicines was established via the Therapeutic...

‘Similar biologics’ approved and marketed in India posted 28/08/2015

Last update: 28 August 2015There have been established guidelines for approving generic versions of small molecule chemi...

Australian approval for infliximab biosimilar posted 28/08/2015

South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Au...

Biosimilars approved in the US posted 28/08/2015

Last update: 14 August 2015In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics...

ACR position statement on biosimilars addresses naming and substitution posted 28/08/2015

The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues suc...

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