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Biosimilars licensing agreements for AMP and Formycon posted 03/07/2015

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

Ranibizumab similar biologic launched in India posted 26/06/2015

Indian generics maker Intas Pharmaceuticals (Intas) announced on 19 June 2015 the launch of its ranibizumab similar biologic...

FDA approves first once-daily glatirimer acetate generic posted 19/06/2015

The US Food and Drug Administration (FDA) announced on 16 April 2015 the approval of the first generic version of glatiramer...

Indian drugmakers make progress with candidate biosimilars posted 10/06/2015

India-based biologicals specialist Biocon announced on 7 May 2015 that it had made clinical progress in its partnered program...

Baxter and Coherus amend biosimilar etanercept collaboration posted 29/05/2015

US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 tha...

 

Research

Norway, biosimilars in different funding systems posted 30/07/2015

Norway has approved biosimilar versions of the biologicals somatropin, epoetin, filgrastim and infliximab. Epoetin and filgra...

Approval of biosimilars in rheumatology posted 30/07/2015

Biosimilars are approved following a regulatory pathway different to that of generics, as they are not molecularly identical...

Real-life results for Inflectra compared to Remicade posted 30/07/2015

Results of a post-marketing clinical study of infliximab biosimilar Inflectra demonstrated equivalent effectiveness compared...

Biosimilars in the US posted 30/07/2015

The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1...

Remsima shows comparable safety and efficacy in IBD patients posted 30/07/2015

South Korean biotechnology company Celltrion presented results of clinical experience for its infliximab biosimilar Remsima (...

 

General

Polish firm gets EIB loan for biosimilars development posted 03/07/2015

The European Investment Bank (EIB) is lending Euros 45 million (around Zloty 185 million) to the largest Polish manufact...

Biosimilars of rituximab posted 03/07/2015

Last update: 3 July 2015Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the...

Concerns raised over Australian decision to substitute biosimilars posted 26/06/2015

In May 2015, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that originator biologicals could be s...

Biosimilars of infliximab posted 26/06/2015

Last update: 26 June 2015Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is use...

Biosimilars of adalimumab posted 26/06/2015

Last update: 26 June 2015Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tu...

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