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EMA approval for insulin and rituximab biosimilars posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it...

Positive phase I results for Cinfa’s pegfilgrastim biosimilar posted 19/05/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 17 May 2017 that results from the second phase I study of it...

Second infliximab biosimilar to be launched in Australia in 2Q 2017 posted 19/05/2017

Merck Sharp and Dohme (MSD) announced on 1 May 2017 its intention to launch the infliximab biosimilar Renflexis in the second...

FDA approves biosimilar infliximab Renflexis posted 12/05/2017

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version...

EMA approval for etanercept and rituximab biosimilars posted 12/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that i...

 

Research

Biosimilars in the treatment of inflammatory bowel disease posted 26/05/2017

Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of...

EMA guidance for NBCDs and products approved posted 26/05/2017

The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has...

Danish infliximab switching study shows no difference posted 26/05/2017

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negat...

Post-marketing experience with IBD biosimilars posted 26/05/2017

The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has r...

Accountability, safety and competition in biologicals markets posted 26/05/2017

Regulatory systems for drug approval aim to reduce the likelihood of drug-related safety problems, but cannot fully eliminate...

 

General

Biosimilars approved in the US posted 26/05/2017

Last update: 26 May 2017In the US, a legal framework for approving biosimilars was established in 2009, via the Biologic...

Biosimilars approved in Europe posted 26/05/2017

Last update: 26 May 2017In the European Union (EU), a legal framework for approving biosimilars was established in 2003....

Biosimilars applications under review by EMA – April 2017 posted 19/05/2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

Biosimilars of teriparatide posted 19/05/2017

Last update: 9 May 2017Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a p...

WHO to launch prequalification programme for biosimilars posted 19/05/2017

The World Health Organization (WHO) announced on 4 May 2017 that it would launch a pilot project for prequalifying biosimilar...

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