Biosimilars

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 its utilization in relation to biosimilars.

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 and Redesca HP.

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 Archigen Biotech has been stopped.

Biosimilars and availability of reference products

Biosimilars/Research | Posted 15/01/2021

A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosimilars [1].

Biosimilars applications under review by EMA – January 2021

Biosimilars/General | Posted 15/01/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

EC approval for pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 15/01/2021

The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.

Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany

Biosimilars/Research | Posted 15/01/2021

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to variations in biosimilar uptake across countries, and even within countries, as was investigated for tumour necrosis factor-alfa (TNF-α) inhibitor biosimilars in Sweden [1, 2]. In Germany, biosimilar market shares are also known to vary at the regional level. This was studied by Blankart et al. for erythropoiesis-stimulating substances, filgrastim and somatropin, and variations in biosimilar market shares were partly attributed to the presence of explicit regional cost-control measures, such as quota regulations [3]. Differences in the uptake of biosimilars have also been described in Germany for the class of TNF-α inhibitors, although reasons behind this variable uptake have not been examined in detail [4].

Positive phase III results for sintilimab plus copy biological Byvasda

Biosimilars/Research | Posted 15/01/2021

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab.

Regulatory challenges with biosimilars

Biosimilars/Research | Posted 08/01/2021

The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [1]. Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.

China approves adalimumab copy biological HLX03

Biosimilars/News | Posted 08/01/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.