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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...

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).

Two more countries added to EU-US mutual recognition agreement Policies & Legislation | Posted 08/03/2019

The European Medicines Agency (EMA) announced on 11 February 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional...

Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec Pharma News | Posted 08/03/2019

Boehringer Ingelheim is the only biosimilar manufacturer still challenging AbbVie’s Humira (adalimumab) patents in court, and has just won a legal battle to gain access to documents AbbVie has foug...

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.

FDA plans to advance development of complex generics in 2019 Guidelines | Posted 08/03/2019

In a statement released on 30 January 2019, US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb outlined the steps FDA will take in 2019 to promote access to complex generic medicines.

Pilot procurement scheme in China cuts drug prices Generics/General | Posted 08/03/2019

The Chinese pharmaceutical market, which is dominated by domestic manufacturers, is the second largest in the world in terms of value after the US. In a bid to lower drug prices for patients and re...

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.