Biosimilars featured in all the most widely read articles in GaBI Online during 2021 and below is a list of the top 10 most read articles in 2021. Follow the links in the titles of each article to find out more …

From this ‘most read’ articles overview, the effect of Canada’s biosimilar substitution policy on competition and patient safety was the most popular, coming in first position. The review found that Canada could learn from the European market, where switching policies retain choice for physicians and patients and promote competition. GaBI Journal published a paper on the subject of Canada’s substitution policy for biosimilars during 2021 [1].

Biosimilar approvals were also very popular, with the EMA’s recommendation to approve two adalimumab biosimilars coming in second position, biosimilars approved in Uruguay and Paraguay in sixth and ninth positions, respectively, and China’s approval of three bevacizumab copy biologicals in tenth position.

During 2021, the European Union (EU) approved one adalimumab biosimilar (Yuflyma), four bevacizumab biosimilars (Abevmy, Alymsys, Onbevzi and Oyavas), an insulin aspart biosimilar (Kirsty), and a ranibizumab biosimilar (Byooviz). While the EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for the approval of the adalimumab biosimilars Hukyndra and Libmyris, and for the bevacizumab biosimilar (Lextemy). These approvals bring the total number of biosimilars approved in the EU to 70 [2].

Meanwhile, also during 2021, the US Food and Drug Administration (FDA) approved three new biosimilars, bringing the total number of biosimilars approved in the US to 33 [3]. The agency also made the landmark decision to approve two biosimilars (Semglee and Cyltezo) as interchangeable [4, 5]. This means that they can be substituted for their reference products without the intervention of the prescriber.

Naming of biosimilars featured once again in the Top 10, with the knowledge and perceptions of naming for biosimilars in the US coming in second position. In fact, the importance of naming for biosimilars is highlighted by the fact that naming has featured in four of the Top 10 articles in the last five years.

In fourth position came an article on how data support the interchangeability of EU biosimilars. This study was the first to comprehensively analyse post-marketing surveillance data for biosimilar monoclonal antibodies and demonstrated comparable efficacy, safety and immunogenicity with the originator products. GaBI Journal published in 2021 a paper on EU quality, safety and clinical development programmes [6].

The fifth most popular article was the federal purchases of biologicals for cancer in Brazil. Buying biosimilars is generally considered to be a way to increase access to cancer treatments. However, an analysis of the profile of purchases of monoclonal antibodies acquired by the Unified Health System (SUS) between 2015 and 2019 showed that this premise might not be true in Brazil.

Litigation against biosimilar makers was also a topic of interest in 2020, with an article on how patent litigation creates barriers to US biosimilar market growth hitting the number eight spot in the list. This article found that combined, non-compliance with the litigation process and large numbers of litigated patents have contributed to frequent confidential settlements between originator and biosimilar manufacturers, which has delayed the availability of biosimilars in the US.

Biosimilar competition was the next most popular topic in 2021, with how competition from biosimilars drives price reductions for biologicals in France taking position eight in the Top 10. The authors of this article concluded that the French experience provides lessons for the US and other nations in their efforts to use competition from biosimilars to drive price reductions and savings from biologicals.

On the subject of generics, COVID-19 was the most interesting topic for GaBI Online readers, with articles on the progress that Pfizer and Merck have made on their COVID-19 anti-virals and the EMA recommendation for a fourth COVID-19 vaccine coming in at first and fifth positions in the Top Five. GaBI Journal published a paper on the subject of biotechnological therapies and biosimilars for COVID-19 in Ecuador during 2021 [7].

Another topic of interest was generics approvals, with the epic milestone of the Food and Drug Administration (FDA) reaching more than 100 generic drug applications with a competitive generic therapy (CGT) designation coming in second position.

In third position in the Top Five list was an article that discussed the fact that the US brand-name drug market exclusivity periods have remained relatively unchanged over the past decade. The aim of the study was to provide updated evidence in three critical economic factors (market exclusivity, patent challenges and rate of generics penetration) that have an important influence on the balance between cost savings from generics and incentives for continued innovation in the form of new brand-name drugs.

Generics applications under review by EMA was also an interesting article for GaBI Online readers. GaBI Online prepares an overview of generics under review by EMA every six months and regularly reports on new generics approvals, especially first-time generics approvals.

Related articles
Top 10 most read GaBI Online articles in 2020

Top 10 most read GaBI Online articles in 2019

References
1. Schneider PJ, Reilly MS. A critical review of substitution policy for biosimilars in Canada. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(3):123-9. doi:10.5639/gabij.2021.1003.016
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangeable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable
6. Zuccarelli M, Micallef B, Cilia M, et al. The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(2):83-99. doi:10.5639/gabij.2021.1002.009
7. Ortiz-Prado E, Teran E, Fernandez Naranjo RP, et al. Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(4):184-92. doi:10.5639/gabij.2021.1004.023

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