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Biosimilars

Brazil flag V13C03

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO

Biosimilars/Research | Posted 15/03/2019

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-on biologicals and compare  regulations in Europe, the US and the world [1].

Rituximab V13D29

China approves rituximab copy biological

Biosimilars/News | Posted 15/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

Chemotherapy V13E17

UK’s NICE recommends pertuzumab with biosimilar trastuzumab

Biosimilars/News | Posted 15/03/2019

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.

NMPA

Copy biologicals approved in China

Biosimilars/General | Posted 15/03/2019

Last update: 2 April 2021

In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).

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Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin

Biosimilars/Research | Posted 15/03/2019

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the originator biological, Roche’s Herceptin (trastuzumab) [1].

EU MedSoc 2016 Cover V15L30DG

Impact of proposed changes to FDA approach to biosimilars

Biosimilars/Research | Posted 08/03/2019

In the Opinion article, Professor Sarfarez Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development [1]. Niazi’s proposals are consistent with the anti-regulatory political rhetoric and administrative actions that are becoming increasingly widespread in the US. In this article, Professor Pekka Kurki comments on some of Niazi’s proposals from a global perspective [2].

Cancer Cell V13I20

EC approval for bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 08/03/2019

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).

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Positive phase I results for Mycenax’s tocilizumab biosimilar

Biosimilars/Research | Posted 08/03/2019

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.

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Green Shield Canada’s biosimilar switch pilot a success

Biosimilars/General | Posted 08/03/2019

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosimilar transition pilot had been successfully completed.

Optional Mandatory V19C01

Mandatory and non-mandatory switching for biosimilars

Biosimilars/Research | Posted 01/03/2019

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].