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Collaboration between regulatory authorities for biosimilars

Biosimilars/Research | Posted 26/02/2021 0 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].

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	Yes^b	Stability data, particularly in‐use stability Verification of administrative information, for example, label, package insert, SmPC, RMP and phase V plan
India^c	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)
Jordan^d	No	EU, US^e	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 procedure^f, WHO PQ, Article 58 of Regulation (EC)^g	EU, US, WHO (SRA PQ procedure)	Yes	Regional information may be required for additional assessment^h
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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Different approaches to the interchangeability of biosimilars

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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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