Collaboration between regulatory authorities for biosimilars

Biosimilars/Research | Posted 26/02/2021 post-comment0 Post your comment

A survey carried out by the World Health Organization (WHO) in 2019‒2020 highlighted the need for collaboration between regulatory authorities in order to expediate the approval of biosimilars [1].

Regulation-V13H16

The results showed that some countries included in the survey used a reliance concept and/or joint review decisions on biosimilar approvals. When using a reliance concept, a regulatory authority recognizes or relies on the decisions of another regulatory authority based on previous expert review where the biosimilar is already licensed. This requires regulatory authorities that adopt this approach to formulate a list of other regulatory authorities whose approvals they will recognize. In some cases, joint review with other regulatory authorities is also undertaken, see Table 1.

Table 1: Collaboration between regulatory authorities for biosimilars
Country Joint review Reliance concept Full reliance Additional assessments
Canada Feasibility under discussion among ACSS None
Ghana Economic Community of West African States (ECOWAS)a EU, US Yesb

Stability data, particularly in‐use stability

 

Verification of administrative information, for example, label, package insert, SmPC, RMP and phase V plan

Indiac No Australia, Brazil, Canada, EU, Japan, US Yes Phase IV study assessment
Iran No EU, US Yes CTD review, laboratory testing, GMP and GCP inspections (if applicable)
Jordand No EU, USe No
Malaysia No EU, US Yes For example, ethnicity
Peru No Canada, EU, ICH, PANDRH, US, WHO No
Singapore Feasibility is under discussion among ACSS None No
Zambia ZAZIBONA collaborative proceduref, WHO PQ, Article 58 of Regulation (EC)g EU, US, WHO (SRA PQ procedure) Yes Regional information may be required for additional assessmenth
Source: WHO.
aMember states of ECOWAS: Benin, Burkina Faso, Cabo Verde, Cote d'Ivoire, Gambia, Ghana, Guinea, Guinea Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone and Togo.
bOn the basis of the Ghana FDA reliance policy (adopted in 2019)
cFor orphan drugs
dFast‐track procedure
eExperienced regulatory authorities
fNational regulatory authorities from participating countries, namely, South Africa, Zimbabwe, Namibia, Botswana, have jointly reviewed dossiers with the Zambia Medicines Regulatory Authority.
gFor certain products, assessment by EMA would help if the Zambian agency is a cohort in the reviews under the article 58 procedure.
hProduction documentation, registration status in the country of origin, registration status in other countries, safety and efficacy bridging studies (may be required in some cases), category for distribution, summary of product characteristics, labelling (outer and inner labels), package leaflet (patient information leaflet), and advertising materials.
ACSS: Australia, Canada, Singapore, Switzerland Consortium; CTD: Common Technical Document; EC: European Commission; EU: European Union; GCP: good clinical practice; GMP: good manufacturing practice; ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; PANDRH: Pan American Network for Drug Regulatory Harmonization; PQ: Prequalification Programme; SRA: Stringent Regulatory Authority; SmPC: summary of product characteristics; RMP: risk management plan; US: United States of America; WHO: World Health Organization.

In addition, EMA, US Food and Drug Administration (FDA), Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency have formed a ‘biosimilars cluster’ to foster global interactions on biosimilars, and EMA and FDA have introduced a joint program to provide manufacturers with parallel scientific advice [2].

There is evidence that the concept of reliance based on information and approval from an experienced regulatory agency in the area of evaluation of post-approval changes of biotherapeutics operates well and improves efficiency in some countries, e.g. Brazil (pilot), Ghana and Singapore. This procedure could therefore offer an opportunity for an efficient and effective regulatory process for biosimilar evaluation in countries with limited resources.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

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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.

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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.

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References
1. Kang HN, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2020 Nov 21. doi: 10.1111/nyas.14522. Epub ahead of print.
2. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-and-FDA-to-collaborate-on-biosimilars 

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