Seeks to provide readers with the latest updates on developments in relation to generic and biosimilar medicines, and to serve as a communication vehicle to reach key members of the healthcare world.
Blog/Websites
Authored by Anna R. Welch, the editor of website Biosimilar Development, this blog covers the development, manufacturing, regulatory, and industry issues related to Biosimilars.
Authored by Dr Duncan Emerton, who has nearly a decade of experience focused on biosimilars, provides insight, opinion and resources for the biosimilars enthusiast.
Guidelines
Presentations
Chao-Yi (Joyce) Wang, Senior Specialist Taiwan FDA. Biosimilar Regulation and Review System in Taiwan DOH, September 5, 2011, Regulation and Development Strategy of Biosimilar Products Conference.
Available here.
Joung Jeewon, Ministry of Food and Drug Safety. Biosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments. April 2014.
Available here.
Arato, T, PhD, Review Director PMDA. Recent Regulations of Biosimilars in Japan. Presented at the 11th Annual Meeting DIA 2011, Chicago IL.
Available here.
Yasuhiro Kishioka, Ph.D. Principal Reviewer Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory Framework for Biotherapeutic Products including Similar Biotherapeutic Products. Presented at the 1st Malaysia-Japan Symposium on Pharmaceutical Regulatory System, March 10-11, 2015, Kuala Lumpur, Malaysia.
Available here.
Tzou, Meir-Chyun, PhD, Director, Division of Medicinal Products, Taiwan Food & Drug Administration, Ministry of Health and Welfare Recent. Trend of Pharmaceutical Regulations in Taiwan. Presented at the 10th Annual Meeting DIA, November 6-8 2013, Japan, Tokyo.
Available here.
Publications
Singh et al., A Comparision of US, Europe, Japan and India Biosimilar Regulations. International Journal of Drug Development and Research 2013, 5(2): 35-39.
Available here.
Kuma et al., Biosimilars: Regulatory Status and Implications across the World. Pharmacoivigilance 2015, s3-002.
Available here.
Castanheira LG, et al. Current development in regulation of similar biotherapeutic products in Brazil. Biologicals 2011;39(5):308-11.
Available here.
Krishnan et al., Global regulatory landscape of biosimilars: emerging and established market perspectives 2015; 5:19—32.
Available here.
Nagai et al., Japanese regulatory authority’s perspective on biosimilars (Op-ed) 2015; Vol 16.
Available here.
Wang et al., On the Regulatory Approval Pathway of Biosimilar Products. Pharmaceuticals 2012; 5(4): 353–368.
Available here.
Yamaguchi, T and Arato, T., Quality, safety and efficacy of follow-on biologics in Japan. Biologicals 2011; 39 (5): 328–332.
Available here.
Suh, SK and Park Y., Regulatory guideline for biosimilar products in Korea. Biologicals 2011; 39 (5): 336-338.
Available here.
Leng, HMJ, et al., Regulatory requirements for the development and registration of biosimilars in South Africa. 2015, 4(3).
Available here.
Klein et al., Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses. Generics and Biosimilars Initiative Journal, 2014; 3(3):150-4.
Available here.
Hechavarría Núñez et al., The regulatory framework for similar biotherapeutic products in Cuba. Biologicals, 2011; 39(5):317-20.
Available here.