Biosimilars applications under review by EMA

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.

All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to EMA [1].

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 7 January 2021, the agency is reviewing 12 biosimilar applications. One application is for diabetes treatment insulin human (rDNA). There are currently no biosimilars for insulin human rDNA approved in Europe [2].

The other applications are one for arthritis treatment adalimumab, five for anticancer treatment bevacizumab, one for neutropenia (a lack of white blood cells) treatment in cancer patients pegfilgrastim, one for vision-loss treatment ranibizumab, two for osteoporosis treatment teriparatide and one for breast and gastric-cancer treatment trastuzumab, for which there are already biosimilars available on the European market [2], see Table 1.

Table 1: Biosimilars under review by EMA*
Common name	Therapeutic area	Number of applications	EMA-approved originator(s)	Originator company(ies)
Adalimumab	Immunosuppressant	1	Humira	AbbVie
Bevacizumab	Antineoplastic medicines (anticancer)	5	Avastin	Roche
Insulin human (rDNA)	Diabetes	1	Actrapid/ Humulin	Novo Nordisk/Eli Lilly
Pegfilgrastim	Immunostimulant (neutropenia)	1	Neulasta	Amgen
Ranibizumab	Ophthalmological (wet AMD)	1	Lucentis	Novartis
Teriparatide	Calcium homeostasis (osteoporosis)	2	Forsteo	Eli Lilly
Trastuzumab	Antineoplastic medicines (anticancer)	1	Herceptin	Roche
Total		12
*Data collected on 15 January 2021. AMD: age-related macular degeneration; rDNA: recombinant deoxyribonucleic acid. Source: EMA.

In June 2020, the bevacizumab biosimilar Aybintio (SB8) and the teriparatide biosimilars Livogiva and Qutavina received positive recommendations from EMA’s CHMP [3]. This was followed by European Commission (EC) approval for Aybintio and Livogiva in August 2020 [2].

In July 2020, the bevacizumab biosimilar Equidacent gained EC approval [4].

Then, in December 2020, EMA’s CHMP recommended approval of the bevacizumab biosimilar Onbevzi [5], insulin aspart biosimilar Kixelle [6] and adalimumab biosimilar Yuflyma [7].

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.

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Equidacent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Equidacent
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of bevacizumab biosimilar Onbevzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-bevacizumab-biosimilar-Onbevzi
6. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of insulin aspart biosimilar Kixelle [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-insulin-aspart-biosimilar-Kixelle
7. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of insulin aspart biosimilar Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-adalimumab-biosimilar-Yuflyma

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA