This article reviews some of the most important events for biosimilars during 2020. For biosimilars these included the World Health Organization’s (WHO) prequalification of its first biosimilar and US Food and Drug Administration (FDA) rules and guidance. Other subjects of interest for biosimilars were European Medicines Agency (EMA) approvals, the biosimilars market in Latin America, biosimilar litigation, and extrapolation, immunogenicity, switching and substitution of biosimilars.
Biosimilars came top of the most read articles in GaBI Online during 2020 and below is a list of the top 10 most read articles in 2020. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, WHO’s prequalification of its first biosimilar, trastuzumab, was the most popular, topping the charts. The breast cancer treatment, which is supplied by Samsung Bioepis, was assessed by WHO and was found to be comparable to the originator product in terms of efficacy, safety and quality. It is now eligible for procurement by United Nations agencies and for national tenders.
The second most popular article was the key issues for adalimumab biosimilars. The issues highlighted included extrapolation, immunogenicity, switching and substitution. The Belgian Inflammatory Bowel Disease (IBD) research group says current uptake of adalimumab biosimilars is low and recommended government action to help get more stakeholders on board with biosimilars. Switching was an issue also raised in the sixth most popular article, which covered the safety of switching between reference products and biosimilars. Concerns about switching has long been an issue for biosimilars. However, the review by Barbier et al. did not indicate or corroborate any major safety concerns related to a switch from a reference product to a biosimilar or vice versa.
FDA rules and guidance were also popular in 2020, with the agency’s new rule on definition of the term ‘biological product’ coming in third position and draft guidance on licensing biosimilars for fewer indications coming in 10th position. FDA also released new information on its website during 2020, that the agency clarifies the difference between biosimilars and interchangeable biologicals . The agency is, however, yet to approve a biosimilar as interchangeable to a reference biological.
EMA approvals of bevacizumab biosimilars, Equidacent and Onbevzi came in fifth and seventh positions in the Top 10 most read. During 2020, Europe approved one adalimumab biosimilar (Amsparity), two bevacizumab biosimilars (Aybintio and Equidacent), one etanercept biosimilar (Nepexto), one insulin aspart biosimilar (Insulin aspart Sanofi), one rituximab biosimilar (Ruxience) and two teriparatide biosimilars (Livogiva and Qutavina), one trastuzumab biosimilar (Zercepac) and one pegfilgrastim biosimilar (Nyvepria). EMA’s Committee for Medicinal Products for Human Use (CHMP) also recommended approval of an adalimumab biosimilar (Yuflyma), a bevacizumab biosimilar (Onbevzi) and an insulin aspart biosimilar (Kixelle) .
Litigation against biosimilar makers was also a topic of interest in 2020, with the patent settlement agreement between Alexion Pharmaceuticals (Alexion) and Amgen hitting the number eight spot in the list. This agreement is expected to delay biosimilars of Alexion’s blockbuster antibody treatment for the blood disease paroxysmal nocturnal haemoglobinuria (PNH) until 2025. Patent litigation against biosimilar makers in the US does seem to be on a downward trend, according to authors Whitehill and Deshmukh. They found that many cases have been resolved and only five cases are still pending as of 31 December 2020 .
Finally, the biosimilars market in Latin America came in ninth position. This review found that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products, while information in other countries is more limited. Another literature review covering current trends for biosimilars in the Latin American market by Claudio Galarza-Maldonado and colleagues was published in GaBI Journal .
On the subject of generics, applications under review and the approval of generics by EMA were the top two most interesting articles for GaBI Online readers. GaBI Online prepares an overview of the generics under review by EMA every six months and regularly reports on new generics approvals, especially first-time generic approvals.
Another topic of interest was pharmacokinetics and generic drug switching. Researchers from the Netherlands shared their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argued that there is no reason to change the current average bioequivalence-based approval pathway for generics.
The outbreak of coronavirus (COVID-19) is also of major interest to many readers, which is reflected by an article on generic remdesivir making it into the Top 5 most read generics articles.
Finally, the impact of Medicare Part D on generics prescribing in long-term care came in fifth position in this list. This observational study, carried out in long-term care facilities in the US, showed that the Medicare Part D programme has no significant effect on the rate of generic drug prescriptions, contrary to expectations.
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Top 10 most read GaBI Online articles in 2019
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LATIN AMERICAN FORUM – Coming soon!
To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
LATIN AMERICAN FORUM – Próximamente!
Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.
Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
1. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/FDA-releases-new-information-on-interchangeable-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar patent litigation trends in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-patent-litigation-trends-in-the-US
4. Galarza-Maldonado C, Intriago D, Checa-Jaramilloz DC, et al. Current trends for biosimilars in the Latin American market. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011
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