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Medicines for Europe 16th Biosimilar Medicines Conference Conferences | Posted 09/02/2018

16th Biosimilar Medicines Conference – Biosimilar Medicines: Unlocking the Full Potential of Biologics 26−27 April 2018 Grange Tower Bridge HotelLondon, UK

The biosimilar landscape in Italy revealed Biosimilars/Research | Posted 02/02/2018

In Italy, health services are run at the regional level. To date, there has been no systematic monitoring of the uptake of biosimilars at a national or regional level. As such, the biosimilar lands...

Interchangeability of gabapentin generics Generics/Research | Posted 02/02/2018

Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin in order to identify potential subpopulations of individual patients wi...

EC approval for bevacizumab biosimilar Mvasi Biosimilars/News | Posted 02/02/2018

Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).

TGA approves three biosimilars but fewer generics in 2017 Reports | Posted 02/02/2018

Australia’s Therapeutic Goods Administration (TGA) approved fewer generics in 2017 (101) compared to 2016 (118). However, 2017 also saw a large proportion of new registrations of immunotherapies an...

China FDA issues draft guidance on drug review and approval transparency Guidelines | Posted 02/02/2018

China Food and Drug Administration (CFDA) announced on 16 January 2018 that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applicati...

FDA accepts applications for adalimumab and trastuzumab biosimilars Biosimilars/News | Posted 02/02/2018

Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars...

Danish etanercept switching study investigates withdrawal rates Biosimilars/Research | Posted 02/02/2018

A study carried out by researchers from Denmark has investigated switching from originator to biosimilar etanercept 1-year post switch [1].