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.

More national guidance needed on biosimilars in Europe

Biosimilars/Research | Posted 08/01/2021

A poster presented at the Virtual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 2020 conference outlines the importance of regulatory guidance on biosimilar medicines in Europe.

EMA and FDA accept application for adalimumab biosimilar AVT02

Biosimilars/News | Posted 08/01/2021

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA, had filed an application for its adalimumab biosimilar (AVT02). The company also announced that the European Medicines Agency (EMA) had accepted for review its application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

Phase I study comparing SB8 with reference bevacizumab

Biosimilars/Research | Posted 08/01/2021

SB8, developed by Samsung Bioepis, was approved as a biosimilar of the reference product Avastin (bevacizumab) by the European Commission in August 2020 with the brand name of Aybintio [1]. The objective of this phase I study was to compare the pharmacokinetics, safety, tolerability and immunogenicity between SB8 and the European Union (EU) and United States (US) reference products (bevacizumab-EU and bevacizumab-US).

Biosimilars in Australia – a-flagging and sustainability

Biosimilars/General | Posted 08/01/2021

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU on similar biological medicinal products [1].

EMA recommends approval of bevacizumab biosimilar Onbevzi

Biosimilars/News | Posted 11/12/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Onbevzi.

Scientific, legal and regulatory challenges facing biosimilars development

Biosimilars/Research | Posted 11/12/2020

Abbreviated approval pathways for biosimilars – biological products that are highly similar to an originator biological with regard to quality, safety and efficacy [1, 2] – were created to foster competition and lower prices for biological treatments. However, these desired effects have not materialized as quickly as expected in either the US or the European Union.

Safety monitoring for immune-modulating biologicals

Biosimilars/Research | Posted 11/12/2020

A study of adverse events among patients with autoimmune disease identifies numerous cases of serious infection. The study also demonstrates the ability of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) to function as a surveillance platform [1].

Biosimilar advances for Samsung Bioepis

Biosimilars/General | Posted 11/12/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has announced several advances related to its infliximab, denosumab and ranibizumab biosimilars. These announcements come after the company revealed soaring sales figure in Europe.

EMA accepts application for bevacizumab biosimilar BAT1706

Biosimilars/News | Posted 04/12/2020

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 25 November 2020 that it had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency (EMA).

Australia approves etanercept and insulin aspart biosimilars

Biosimilars/News | Posted 04/12/2020

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), announced in October 2020 the approval of etanercept and insulin aspart biosimilars.

Real-world data on biosimilars in inflammatory arthritis treatment

Biosimilars/Research | Posted 04/12/2020

The use of biologicals in patients with rheumatic diseases has achieved the therapeutic target, i.e. remission or low disease activity. The share of biologicals has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics and immunogenicity to the originator, as well as their reduced economic burden.