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 9 July 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 two for arthritis treatment adalimumab, one for anticancer treatment bevacizumab, one for diabetes treatment insulin aspart, one for neutropenia (a lack of white blood cells) treatment in cancer patients pegfilgrastim, four for osteoporosis treatment teriparatide and two 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
|
2
|
Humira
|
AbbVie
|
| Bevacizumab
|
Antineoplastic medicines (anticancer)
|
1
|
Avastin
|
Roche
|
| Insulin aspart
|
Diabetes
|
1
|
NovoLog
|
Novo Nordisk
|
| Insulin human (rDNA)
|
Diabetes
|
1
|
Actrapid/
Humulin
|
Novo Nordisk/
Eli Lilly
|
| Pegfilgrastim
|
Immunostimulant (neutropenia)
|
1
|
Neulasta
|
Amgen
|
| Teriparatide
|
Calcium homeostasis (osteoporosis)
|
4
|
Forsteo
|
Eli Lilly
|
| Trastuzumab
|
Antineoplastic medicines (anticancer)
|
2
|
Herceptin
|
Roche
|
| Total
|
|
12
|
|
|
*Data collected on 30 July 2021.
rDNA: recombinant deoxyribonucleic acid.
Source: EMA.
|
The bevacizumab biosimilars Alymsys and Oyavas (MB02) were approved in Europe in March 2021 [3] and Abevmy (MYL 1402O) was approved in April 2021 [4]. While the bevacizumab biosimilar Lextemy received a positive recommendation from the EMA’s CHMP in February 2021.
Then, in June 2021, the EMA’s CHMP recommended approval of the ranibizumab biosimilar Byooviz [5].
Related articles
Generics applications under review by EMA – July 2021
Biosimilars applications under review by EMA – January 2021
| LATIN AMERICAN FORUM The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Solicitudes de biosimilares bajo evaluación de la EMA - julio de 2021 Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Solicitudes de biosimilares bajo evaluación de la EMA - julio de 2021 Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. 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 Jul 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Alymsys/Oyavas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-bevacizumab-biosimilar-Alymsys-Oyavas
4. GaBI Online - Generics and Biosimilars Initiative. EC approves bevacizumab biosimilar Abevmy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/EC-approves-bevacizumab-biosimilar-Abevmy
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
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