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Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies Generics/General | Posted 13/12/2019

Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health and Long-Term Care (the Ministry) is proposing a number of changes to stre...

FDA issues updated guidance on implementing GDUFA II Guidelines | Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

Australia approves five biosimilars since June 2019 Biosimilars/News | Posted 06/12/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosi...

Health Canada publishes biosimilars fact sheet Guidelines | Posted 06/12/2019

Health Canada has published a fact sheet on biosimilars, which aims to provide a comprehensive overview on a number of issues concerning biosimilars.

How to support a viable US biosimilars market Reports | Posted 06/12/2019

In a previous article Ms Juliana Reed, President of the Biosimilars Forum, outlined why the US biosimilars market is sluggish at the DIA Biosimilars Conference, which was held on 23‒24 September 20...

Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia Biosimilars/Research | Posted 06/12/2019

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

WHO prequalifies antiparasitic API Generics/General | Posted 06/12/2019

The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuticals Ltd, as an active pharmaceutical ingredient (API).

Phase III trials started for bevacizumab and natalizumab biosimilars Biosimilars/News | Posted 06/12/2019

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.