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Biosimilars and lack of resources Biosimilars/Research | Posted 22/01/2021

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...

EMA recommends approval of adalimumab and insulin aspart biosimilars Biosimilars/News | Posted 22/01/2021

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...

How organizations worldwide are producing HTA reports for biosimilars Biosimilars/Research | Posted 22/01/2021

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...

Generics applications under review by EMA – January 2021 Generics/General | Posted 22/01/2021

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...

Key considerations for payers, employers and patients in the US biosimilars market Reports | Posted 22/01/2021

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...

Canada approves heparin biosimilars Redesca and Redesca HP Biosimilars/News | Posted 22/01/2021

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...

FDA increases transparency of biosimilar applications Guidelines | Posted 22/01/2021

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.

Samsung biosimilars: denosumab clinical trials begin, while rituximab development is halted Biosimilars/General | Posted 22/01/2021

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...