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 4 January 2022, the agency is reviewing 13 biosimilar applications. One application is for haemophilia treatment eptacog alfa and one is for diabetes treatment insulin human (rDNA). There are currently no biosimilars for these products approved in Europe [2].
The other applications are two for anticancer treatment bevacizumab, one for diabetes treatment insulin aspart, three for neutropenia (a lack of white blood cells) treatment in cancer patients pegfilgrastim, three 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)
|
| Bevacizumab
|
Anti‑neoplastic medicines (anticancer)
|
2
|
Avastin
|
Roche
|
| Eptacog alfa
|
Anti‑haemorrhagic (haemophilia)
|
1
|
NovoSeven
|
Novo Nordisk
|
| Insulin aspart
|
Diabetes
|
1
|
NovoLog
|
Novo Nordisk
|
| Insulin human (rDNA)
|
Diabetes
|
1
|
Actrapid/ Humulin
|
Novo Nordisk/ Eli Lilly
|
| Pegfilgrastim
|
Immunostimulant (neutropenia)
|
3
|
Neulasta
|
Amgen
|
| Teriparatide
|
Calcium homeostasis (osteoporosis)
|
3
|
Forsteo
|
Eli Lilly
|
| Trastuzumab
|
Antineoplastic medicines (anticancer)
|
2
|
Herceptin
|
Roche
|
| Total
|
|
13
|
|
|
*Data collected on 18 January 2022.
rDNA: recombinant deoxyribonucleic acid.
Source: EMA.
|
The ranibizumab biosimilar Byooviz was approved in Europe in August 2021 [3].
Then, in October 2021, the EMA’s CHMP recommended approval of the adalimumab biosimilars Hukyndra and Libmyris [4].
Related articles
Biosimilars applications under review by EMA – July 2021
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. 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 2022 Jan 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC and FDA approval for first ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/biosimilars/news/EC-and-FDA-approval-for-first-ranibizumab-biosimilar-Byooviz
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/biosimilars/news/EMA-recommends-approval-of-two-adalimumab-biosimilars
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