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Biosimilar rituximab approved in South Korea posted 02/12/2016

South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rit...

Mylan and Biocon submit insulin glargine biosimilar to EMA posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regula...

FDA accepts application for bevacizumab biosimilar posted 25/11/2016

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed b...

EMA approves biosimilars of insulin glargine and teriparatide posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 tha...

Celltrion submits trastuzumab biosimilar application to EMA posted 18/11/2016

South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to...

 

Research

Biosimilars help reduce the costs of cancer care posted 02/12/2016

The costs for cancer drugs have been increasing significantly in countries around the world. With the arrival of new therapie...

Safety differences in clinical trials for biosimilars posted 02/12/2016

Differences in safety evaluations and findings between clinical trials for biosimilars are highlighted by researchers from th...

Assessing analytical comparability for G-CSF biosimilars posted 02/12/2016

According to the US Food and Drug Administration (FDA), a biosimilar is a biological product shown to be ‘highly similar to a...

Extrapolation of indications for biosimilar infliximab and etanercept posted 02/12/2016

Biosimilar infliximab (Inflectra/Remsima) was approved in Europe in September 2013 for the same indications as the originator...

Trials for biosimilar etanercept posted 02/12/2016

Biosimilar etanercept was approved in Europe in January 2016 [1]. Researchers from the National Health Service (NHS) Foundati...

 

General

Biosimilars of abatacept posted 02/12/2016

Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid arthritis, by interfering...

Biosimilars approved in South Korea posted 02/12/2016

Last update: 2 December 2016In South Korea, the regulatory body for the approval of medicines, including biologicals and...

Biosimilars of insulin glargine posted 02/12/2016

Last update: 2 December 2016Insulin glargine is a long-acting basal insulin analogue, given once daily to help control t...

Portuguese dermatologists’ position on the use of biosimilars in psoriasis posted 01/12/2016

Biologicals have revolutionized the treatment of psoriasis and psoriatic arthritis. However, they impose a heavy bu...

Biosimilars approved in Europe posted 25/11/2016

Last update: 25 November 2016In the European Union (EU), a legal framework for approving biosimilars was established in...

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