Biosimilars
FDA approves rituximab biosimilar Riabni
US-based biotech giant Amgen announced on 17 December 2020 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar Riabni (ABP 798).
Biosimilars and lack of resources
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 principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain. Lack of resources was one of the challenges identified from the results of the survey.
EMA recommends approval of adalimumab and insulin aspart biosimilars
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 biosimilar Yuflyma and for the insulin aspart biosimilar Kixelle.
How organizations worldwide are producing HTA reports for biosimilars
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
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
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
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
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
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
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].
