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Joint 26th Medicines for Europe and 23rd IGBA Annual Conference 2021 Conferences | Posted 21/02/2020

Joint 26th Medicines for Europe and 23rd IGBA Annual Conference 2021 8–10 June 2021 Divani Apollon Hotel, AthensGreece

FDA issues draft guidance on licensing biosimilars for fewer indications Guidelines | Posted 14/02/2020

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originato...

Pfizer launching biosimilars in US and Japan but not in EU Biosimilars/News | Posted 14/02/2020

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

Relative bioavailability of FKB327 when administered using different methods Biosimilars/Research | Posted 14/02/2020

FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency appr...

Phase III trial started in China for eculizumab copy biological Biosimilars/News | Posted 14/02/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alex...

Achieving fairer prices for generics and biosimilars Biosimilars/Research | Posted 14/02/2020

Access to safe, effective, quality assured, and affordable essential medicines and vaccines for all has been identified as key to achieving universal health coverage and financial protection. Howev...

Irish pharmaceutical association urges political parties to create a new medicines policy Generics/General | Posted 14/02/2020

The Irish Pharmaceutical Healthcare Association (IPHA) has urged political parties to mandate new policy to increase access to medicines ahead of the Irish general election, which was held on 8 Feb...

US health insurers partner with generics maker Civica Pharma News | Posted 14/02/2020

The Blue Cross Blue Shield Association (BCBSA), a federation of health insurers in the US, has formed a partnership with generics manufacturer Civica Rx to reduce the costs of generic drugs.