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Biosimilars applications under review by EMA – January 2021 posted 18/01/2021

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

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...

ST002293 EMA recommends approval of bevacizumab biosimilar Onbevzi posted 11/12/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 tha...

 

Research

Biosimilars and availability of reference products posted 18/01/2021

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 18/01/2021

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 18/01/2021

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

Regulatory challenges with biosimilars posted 14/01/2021

The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its...

More national guidance needed on biosimilars in Europe posted 11/01/2021

A poster presented at the Virtual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 2020 conference&n...

 

General

Biosimilars of trastuzumab posted 19/01/2021

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

Biosimilars of pegfilgrastim posted 19/01/2021

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

Biosimilars in Australia – a-flagging and sustainability posted 19/01/2021

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU...

Biosimilars of rituximab posted 19/01/2021

Last update: 8 January 2021Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily foun...

Biosimilar advances for Samsung Bioepis posted 19/01/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has announced several advances related to its infliximab, de...

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