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EMA approves biosimilar insulin posted 04/07/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 27 June 2014 that...

Darbopoetin alfa ‘similar biologic’ launched in India posted 20/06/2014

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

Oncobiologics and IPCA create biosimilars alliance posted 16/06/2014

US-based Oncobiologics announced on 2 June 2014 the creation of a two-part alliance for the development, manufacture and comm...

Biosimilars developer Coherus raises US$55 million investment posted 06/06/2014

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 19 May 2014 that it had raised investments of US$55...

Celltrion starts phase III biosimilar trastuzumab trial posted 04/06/2014

South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate...

 

Research

Biosimilar etanercept demonstrates equivalent efficacy posted 04/07/2014

A phase III trial comparing Hanwha Chemical Corporation (Hanwha)’s biosimilar etanercept, HD203, with Enbrel (etanercept) has...

Biosimilar infliximab comparable to Remicade posted 03/07/2014

Results from a phase III trial have demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar...

Can the pursuit of biosimilar interchangeability go too far? posted 20/06/2014

The question of biosimilar interchangeability – whether or not a biosimilar can safely be switched with another biosimilar or...

Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo posted 04/06/2014

Synthon announced on 2 April 2014 that its antibody-drug conjugate SYD985 had outperformed Roche’s breast cancer blockbuster...

Biosimilar epoetin shows good safety profile in post-authorization study posted 04/06/2014

US-based generics manufacturer Hospira announced on 28 April 2014 positive results from a post-authorization observational sa...

 

General

32 organizations agree biosimilars should have same names posted 04/07/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals...

Biosimilars approved in Europe posted 04/07/2014

Last update: 4 July 2014 In the European Union (EU), a legal framework for approving biosimilars was established in 2003...

ECCO position statement on biosimilars posted 03/07/2014

The European Crohn’s and Colitis Organisation (ECCO) is a non-profit association with the aim of improving the care of patien...

Biosimilars of etanercept posted 03/07/2014

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflamm...

Biosimilars of epoetin alfa posted 03/07/2014

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesi...

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