Registration of similar biological products - Singapore's approach

Biologicals

Volumn 39, Issue 5, 2011, Pages 343-345

  Poh, Jalene ^a   Tam, Kai Tong ^a  

^a HEALTH SCIENCES AUTHORITY   (Singapore)

Author keywords

Biosimilar; Similar biological product; Singapore guidelines

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG;

ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG INFORMATION; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE ACCESS; HEALTH CARE ORGANIZATION; MEDICAL DOCUMENTATION; PATENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGISTRATION; SINGAPORE;

DRUG APPROVAL; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; SINGAPORE;

EID: 80053576906     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.011     Document Type: Article

References (14)

1. Guidance on Registration of Similar Biological Products in Singapore. Effective 1 August 2009. http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.94317.File.dat/GuidanceonRegistrationofSimilarBiologicalProductsinSingapore.pdf.
2. CHMP Guideline on Similar Biological Medicinal Products. Effective October 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf.
3. CHMP Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. Effective June 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf.
4. CHMP Guideline on Comparability of Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. Effective December 2003. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pdf.
5. CHMP Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Effective June 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf.
6. WHO Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
7. Guidance on Registration of Medicinal Products in Singapore. Effective 1 January 2009. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medicines/guidelines.html.
8. CHMP Draft Guideline on Similar Biological Medicinal Products containing Monoclonal Antibodies. http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500099361&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc.
9. CHMP Guideline on Similar Biological Medicinal Products containing Recombinant Erythropoietins. Effective 30 September 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf.
10. CHMP Guideline on Similar Biological Medicinal Products containing Low-Molecular-Weight-Heparins. Effective October 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003927.pdf.
11. CHMP Guideline on Similar Biological Medicinal Products containing Recombinant Interferon Alpha. Effective April 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003930.pdf.
12. CHMP Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Recombinant Granulocyte-Colony Stimulating Factor. Effective June 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003955.pdf.
13. CHMP Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Somatropin. Effective June 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003956.pdf.
14. CHMP Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Recombinant Human Insulin. Effective June 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003957.pdf.