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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... 
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... 
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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Biosimilars
General
News
- Biosimilars applications under review by EMA – January 2021
- EC approval for pegfilgrastim biosimilar Nyvepria
Research
Generics News Research General
- Perspectives of prescribing practices in public...Generics/Research | Posted 15/01/2021
- A European pharmaceutical strategy promoting ge...Generics/General | Posted 08/01/2021
- Familiarity with substitution of prescription g...Generics/Research | Posted 11/12/2020
- Cost savings after switching to generic tacrolimusGenerics/Research | Posted 04/12/2020
Biosimilars News Research General
- Biosimilars of trastuzumabBiosimilars/General | Posted 19/09/2014
- Biosimilars of pegfilgrastimBiosimilars/General | Posted 31/10/2014
- Biosimilars in Australia – a-flagging and susta...Biosimilars/General | Posted 08/01/2021
- Biosimilars of rituximabBiosimilars/General | Posted 27/02/2015