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M18 – Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs

Guideline number: M18

This topic was endorsed by the ICH Assembly in May 2025, and the M18 Working Group has been established to develop a final Concept Paper.

Endorsed Documents

Ongoing public consultations

No results found.

M18 Expert Working Group

Rapporteur

Dr. Sarah YimFDA, United States

Regulatory Chair

Mr. João Tavares NetoANVISA, Brazil

Experts

Swissmedic, SwitzerlandDr. Pascal Crottet
Swissmedic, SwitzerlandDr. Arunas Gircys
ANMAT, ArgentinaDr. Eliana Cela
ANVISA, BrazilMs. Cassia de Paula Roesler Savino
CECMED, CubaDr. Lisett Baez Cubas
CPPS, UzbekistanMs. Etel Faradjeva
DINAVISA, ParaguayMs. Adriana Zacarias Chamorro
EC, EuropeDr. René Anour
EC, EuropeDr. Niklas Ekman
EDA, EgyptDr. Hebatallah Abdallatif
EFPIADr. Jens Heisterberg
FDA, United StatesDr. Nina Brahme
FDA, United StatesDr. Stacey Ricci
Health Canada, CanadaDr. Bradley Scott
IFPMADr. Changlin Dou
IFPMAMs. Priscila Rodrigues Simões
IGBADr. Martin Schiestl
IGBADr. Gillian Woollett
JFDA, JordanMs. Ahlam Abdelaziz
JPMADr. Ryutaro Hirasawa
JPMAMr. Shuhei Tsukamoto
MFDS, Republic of KoreaDr. Changjoon Bae
MHLW/PMDA, JapanMs. Kanoko Goto
MHLW/PMDA, JapanDr. Naohiro Otaki
MHRA, UKMs. Francis Galaway
MOH, KuwaitMs. Fatemah Alsalman
NMPA, ChinaDr. Wenbo Sai
NPRA, MalaysiaDr. Azizah Ab Ghani
PhRMADr. Leah Christl
PPBHK, Hong Kong, ChinaMs. Wing Man (Serena) Au
Roszdravnadzor, RussiaMs. Anna Gubenko
SFDA, Saudi ArabiaDr. Ali Al-Samil
TFDA, Chinese TaipeiDr. Yun-Zhe Wu
TITCK, TürkiyeDr. Sevinç Ayla Ozsar
USPDr. Diane McCarthy

Rapporteur Supporter

Dr. Tiffany PfundtFDA, United States

Alternate

Ms. Gabriela BravoANMAT, Argentina
Mr. Matheus Gabriel de OliveiraANVISA, Brazil
Ms. Virginia AchaEFPIA
Chantal DepatieHealth Canada, Canada
Dr. Jin LiIFPMA
Dr. Bayan AlhiasatJFDA, Jordan
Dr. Duanduan CongNMPA, China
Dr. Sharon Shi Min NgNPRA, Malaysia
Dr. Chi-Hsun ChenTFDA, Chinese Taipei
Mr. Bartu AltıparmakTITCK, Türkiye
Dr. Niomi PeckhamUSP