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China approves rituximab copy biological posted 18/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on...

UK’s NICE recommends pertuzumab with biosimilar trastuzumab posted 18/03/2019

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous bios...

EC approval for bevacizumab biosimilar Zirabev posted 08/03/2019

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval f...

Monoclonal antibody copy biologicals accepted for review in China posted 04/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted...

EC approval for pegfilgrastim biosimilar Fulphila posted 22/02/2019

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

 

Research

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO posted 18/03/2019

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-o...

Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin posted 18/03/2019

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the ori...

Positive phase I results for Mycenax’s tocilizumab biosimilar posted 14/03/2019

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab...

EU MedSoc 2016 Cover V15L30DG Impact of proposed changes to FDA approach to biosimilars posted 11/03/2019

In the Opinion article, Professor Sarfarez Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its g...

Positive phase III results for rituximab biosimilar ABP 798 posted 04/03/2019

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rit...

 

General

Copy biologicals approved in China posted 18/03/2019

In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administ...

Biosimilars of filgrastim posted 18/03/2019

Last update: 25 January 2019Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be u...

Pfizer drops five preclinical biosimilar programmes posted 15/03/2019

US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes afte...

Green Shield Canada’s biosimilar switch pilot a success posted 08/03/2019

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosim...

Adalimumab biosimilar Imraldi makes waves in Europe posted 26/02/2019

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab bios...