Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Figures & data

Table 1. Examples of Regulatory Guidance for Biosimilars Medicinal Product Development from around the World.

Region/Country	Regulatory Guidance
Global	WHO Guideline on evaluation of similar biotherapeutic products http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
European Union	EU Guideline on Similar Biological Medicinal Products (CHMP/437/04) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf EU Guideline on similar biological medicinal products containing monoclonal antibodies – nonclinical and clinical issues (EMA/CHMP/BMWP/403543/2010) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
United States of America	Scientific Considerations in Demonstrating Biosimilarity to a Reference Product(Finalised April 2015) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
China	Guidance for research and evaluation techniques for biosimilars(Finalised February 2015) http://www.cde.org.cn/zdyz.do?method=largePageandid=212
Canada	Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf
Japan	PMDA Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics http://www.pmda.go.jp/files/000153851.pdf
India	Similar Biologics: Regulatory requirements for Market Authorization in India (15th Sept, 2012) http://cdsco.nic.in/writereaddata/Bio%20Similar%20Guideline.pdf
Cuba	Center for State Control on the Quality of Drugs (CECMED) Requirements for marketing authorization of known biological products http://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/reg_56–11_requisitos_para_el_registro_de_productos_biologicos_conocidos.pdf
Iran	Guidelines for registration of biologicals (recombinant medicines and monoclonal antibodies) in Iran - Iranian Food and Drug Organization (FDO) (15 March 2014)The guideline, which is in the local language (Farsi), is available from the FDO website: http://fdo.behdasht.gov.ir/
Korea	Korea Evaluation Guidelines for Biosimilars (KFDA, July 2009) http://www.biosimilars.ca/docs/Evalutation_Guidelines_for_Biosimilars.pdf
Australia	Therapeutic Goods Administration: Evaluation of Biosimilars https://www.tga.gov.au/publication/evaluation-biosimilars
Mexico	Guidelines for Biocomparable Biotechnological Products http://dof.gob.mx/nota_detalle.php?codigo=5214882andfecha=19/10/2011
Singapore	Guidance on registration of similar biological products in Singapore. http://www.biosimilars.ca/docs/Guidance_Registration_Similar_Biological_Products_Singapore.pdf
Saudi Arabia	Saudi Food and Drug Authority: Biosimilar Guidelines http://old.sfda.gov.sa/en/drug/news/documents/DrugMasterFileRequirementsforRegistrationofBiosimi.pdf