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The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020 [1] revealed that, despite the efforts of the organization in helping Member States implement the evaluation...
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting marketing authorization for the adalimumab...
The vital contribution of Health Technology Assessment (HTA) is well recognized and consolidated in scientific and technological practice; however, there is still no generally accepted position on...
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...
While financial savings are important for driving biosimilar uptake, they are not the only consideration for payers and providers. Other factors include manufacturer reputation for producing high-q...
Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada, had approved its low molecular weight heparin (LMWH) biosimilars Redesca...
The US Food and Drug Administration (FDA) has made changes to the review of its Biologics License Applications (BLAs) in order to improve transparency and communication.
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar, while development on a rituximab biosimilar through subsidiary company...
Generics News Research General
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Biosimilars News Research General
- Samsung biosimilars: denosumab clinical trials...Biosimilars/General | Posted 22/01/2021
- Biosimilars of filgrastimBiosimilars/General | Posted 20/03/2015
- Biosimilars applications under review by EMA –...Biosimilars/General | Posted 15/01/2021
- EMA recommends approval of adalimumab and insul...Biosimilars/News | Posted 22/01/2021