Biosimilars applications under review by EMA – July 2020

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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 8 June 2020, the agency is reviewing 16 biosimilar applications.

One application is for the immunosuppressant adalimumab, six are for the cancer treatment bevacizumab, one is for the hormone used to treat low blood sugar glucagon, one is for the manufactured insulin product insulin aspart and one is for human insulin (rDNA) – both are for the diabetes treatment, two are for pegfilgrastim, which is used to stimulate neutrophil production in patients undergoing chemotherapy, three are for the osteoporosis treatment teriparatide, and one is for the cancer treatment trastuzumab, 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 medicine (anticancer) 6 Avastin Roche
Glucagon Pancreatic hormones 1 Baqsimi Eli Lilly
Insulin aspart Diabetes 1 NovoLog Novo Nordisk
Insulin human (rDNA) Diabetes 1

Actrapid

Mixtard

Protaphane

Insulatard

Actraphane

Insuman

Novo Nordisk

Novo Nordisk

Novo Nordisk

Novo Nordisk

Novo Nordisk

Novo Nordisk

Pegfilgrastim Immunostimulant (neutropenia) 2 Neulasta Amgen
Teriparatide Calcium homeostasis 3 Forteo/Forsteo Eli Lilly
Trastuzumab Antineoplastic medicine (anticancer) 1 Herceptin Roche
Total   16    
*Data collected on 30 June 2020.
Source: EMA.

There are already biosimilars available on the European market to all these products, excluding glucagon, insulin aspart and insulin human (rDNA) [2].

The CHMP has recently recommended approval of the trastuzumab biosimilar Zercepac, which is manufactured by China-based drugmaker Henlius [3].

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Generics applications under review by EMA – July 2020

Biosimilars applications under review by EMA – January 2020

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. 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 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-trastuzumab-biosimilar-Zercepac

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