Biosimilars applications under review by EMA – January 2022

Biosimilares/General | Posted 21/01/2022 post-comment0 Post your comment

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.

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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].

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Biosimilars applications under review by EMA – July 2021

LATIN AMERICAN FORUM

The new section of 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.

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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 la semana pasada: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos en América Latina

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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 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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Source: EMA

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