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EMA approval for etanercept and rituximab biosimilars posted 28/04/2017

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

Advances in ranibizumab and teriparatide biosimilars posted 21/04/2017

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Trastuzumab biosimilar submitted for approval in Japan posted 14/04/2017

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-...

Basal analogue insulin ‘copy biological’ launched in Indonesia posted 07/04/2017

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biolog...

EC approval for adalimumab biosimilar Amgevita posted 07/04/2017

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its...

 

Research

Prospective study finds switching to biosimilar infliximab safe posted 28/04/2017

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar...

Rituximab biosimilar safe in advanced follicular lymphoma patients posted 21/04/2017

A study of the rituximab biosimilar CT‑P10 has, according to the authors, ‘demonstrated’ similar pharmacokinetics (PK) and sa...

Harmonization of requirements for NBCDs across regions posted 21/04/2017

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products...

US pharmacists’ views on the naming and labelling of biologicals posted 14/04/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmaci...

Italian study compares epoetin biosimilars and originator biologicals posted 14/04/2017

Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Servic...

 

General

Fujifilm ramps up biosimilars production as UK court allows Humira biosimilar posted 28/04/2017

A UK court has ruled in the favour of Japan-based Fujifilm Kyowa Kirin Biologics’ Humira biosimilar. The Fujifilm corporation...

Biosimilars of etanercept posted 28/04/2017

Last update: 28 April 2017Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis...

Biosimilars of abatacept posted 28/04/2017

Last update: 28 April 2017Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid...

Biosimilars of certolizumab pegol posted 25/04/2017

Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEG...

Biosimilars of trastuzumab posted 25/04/2017

Last update: 21 April 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor re...

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