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EMA recommends approval of adalimumab and insulin aspart biosimilars posted 22/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 tha...

Canada approves heparin biosimilars Redesca and Redesca HP posted 22/01/2021

Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada,...

EC approval for pegfilgrastim biosimilar Nyvepria posted 18/01/2021

The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), dev...

EMA and FDA accept application for ranibizumab biosimilar AVT02 posted 08/01/2021

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA...

China approves adalimumab copy biological HLX03 posted 08/01/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products...

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Research

Biosimilars and lack of resources 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 effort...

How organizations worldwide are producing HTA reports for biosimilars posted 22/01/2021

The vital contribution of Health Technology Assessment (HTA) is well recognized and consolidated in scientific and technologi...

Biosimilars and availability of reference products posted 22/01/2021

A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosim...

19646665_l Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany posted 22/01/2021

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of phar...

Positive phase III results for sintilimab plus copy biological Byvasda posted 22/01/2021

China-based drugmaker Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab b...

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General

Samsung biosimilars: denosumab clinical trials begin, while rituximab development is halted posted 26/01/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar,...

Biosimilars of filgrastim posted 26/01/2021

Last update: 22 January 2021Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be u...

Biosimilars applications under review by EMA – January 2021 posted 26/01/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

Biosimilars of pegfilgrastim posted 22/01/2021

Last update: 15 January 2021Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating fa...

Biosimilars of trastuzumab posted 22/01/2021

Last update: 15 January 2021Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growt...

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