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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.

Samsung Bioepis expands biosimilars agreement with Biogen Pharma News | Posted 06/12/2019

Korean biosimilars giant Samsung Bioepis has extended its commercialization agreement with Biogen to include biosimilars to two ophthalmology drugs, Lucentis (ranibizumab) and Eylea (aflibercept)....

EMA recommends approval for two new generics Generics/News | Posted 06/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: Clopidogrel/Acetylsalicylic acid a...