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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].

New safety requirements for EU medicines Policies & Legislation | Posted 15/03/2019

As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are legally obligated to have a unique identifier (a two-dimension barcode...

Escalating prices of generic drugs in the US Generics/Research | Posted 15/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and tw...

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.