Biosimilars
Copy biologicals approved in China
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).
Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin
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].
Impact of proposed changes to FDA approach to biosimilars
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].
EC approval for bevacizumab biosimilar Zirabev
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).
Positive phase I results for Mycenax’s tocilizumab biosimilar
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.
Green Shield Canada’s biosimilar switch pilot a success
Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosimilar transition pilot had been successfully completed.
Mandatory and non-mandatory switching for biosimilars
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].
Monoclonal antibody copy biologicals accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).
Positive phase III results for rituximab biosimilar ABP 798
Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).
Pfizer drops five preclinical biosimilar programmes
US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.
