Global regulatory landscape of biosimilars: emerging and established market perspectives

References

• Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111–5117.
   PubMed Web of Science ®Google Scholar
• Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–419.
   PubMed Web of Science ®Google Scholar
• US FDA. How drugs are developed and approved [webpage on the Internet]. Silver Spring, MD: US FDA; 2014. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm. Accessed August 25, 2014.
   Google Scholar
• EMA. Guideline on similar biological medicinal products [webpage on the Internet]. Canary Wharf, London: EMA; 2005. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf. Accessed August 25, 2014.
   Google Scholar
• Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs) [webpage on the Internet]. Geneva, Switzerland: WHO; 2009. Available at: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf?ua=1. Accessed August 25, 2014.
   Google Scholar
• Korean Food and Drug Administration. Evaluation Guidelines for Biosimilars [webpage on the Internet]. KFDA; 2009. Available at: http://www.biosimilars.ca/docs/Evalutation_Guidelines_for_Biosimilars.pdf. Accessed August 25, 2014.
   Google Scholar
• Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) [webpage on the Internet]. Ottawa, Ontario, Canada: Health Canada; 2010. Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf. Accessed August 25, 2014.
   Google Scholar
• Government of India. Guideline on similar biologics: Regulatory requirements for marketing authorization in India [webpage on the Internet]. Government of India; 2012. Available at: http://dbtbiosafety.nic.in/Files%5CCDSCO-DBTSimilarBiologicsfinal.pdf. Accessed August 25, 2014.
   Google Scholar
• US Department of Health and Human Services. Guidance for industry. Scientific considerations in demonstrating biosimilarity to a reference product [webpage on the Internet]. Rockville, MD: Food and Drug Administration; 2012. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed August 25, 2014.
   Google Scholar
• US Department of Health and Human Services. Guidance for industry. Quality considerations in demonstrating biosimilarity to a reference product [webpage on the Internet]. Rockville, MD: Food and Drug Administration; 2012. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed August 25, 2014.
   Google Scholar
• IMS Health. Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape [webpage on the Internet]. London, UK: IMS Health; 2011. Available at: http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf. Accessed August 25, 2014.
   Google Scholar
• Genetics and Biosimilars Initiative. US $ 54 billion worth of biosimilar patents expiring before 2020 [webpage on the Internet]. GaBI; 2011. Available at: http://www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020. Accessed August 25, 2014.
   Google Scholar
• European Medicines Agency. Biosimilar medicines – Biosimilar medicines authorised via the Agency [webpage on the Internet]. London, UK: European Medicines Agency. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac0580281bf0. Accessed August 25, 2014.
   Google Scholar
• Guidance on registration of similar biological products in Singapore [webpage on the Internet]. 2011. Available at: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Appendix%2017_Guidance%20on%20Registration%20of%20Similar%20Biological%20Products%20in%20Singapore%202011.pdf. Accessed January 20, 2015.
   Google Scholar
• Wang J, Chow SC. On the regulatory approval pathway of biosimilar products. Pharmaceuticals (Basel). 2012;5(4):353–368.
   PubMedGoogle Scholar
• Guise JW, Carson BM. Biogeneric regulatory policies in China and India: a comparison study. Drug Information Journal. 2010;44:55–67.
   Google Scholar
• Tzeng L. Follow-on biologics, data exclusivity, and the FDA. Berkeley Technology Law Journal. 2010;25(1):135–158.
   Google Scholar
• Genetics and Biosimilars Initiative. Biosimilars marketed in Europe [webpage on the Internet]. GaBI; 2012. Available at: http://www.gabionline.net/Reports/Biosimilars-marketed-in-Europe. Accessed August 25, 2014.
   Google Scholar
• BCC Research. Biosimilars: Global Markets. [webpage on the Internet]. Wellesley, MA: BCC Research; 2012. Available at: http://www.bccresearch.com/market-research/biotechnology/biosimilars-global-market-bio090a.html#gsc.tab=0. Accessed August 25, 2014.
   Google Scholar
• Pharmatching Portrays. Pharma & Outsourcing Practice. Biosimilars|Guidelines|Players|Providers [webpage on the Internet]. Pharmatching; 2012. Available at: https://www.pharmatching.com/inforena/pharma-outsourcing-practice-biosimilars-guidelines-players-providers/download/91146/Pharmatching_Portrays_Biosimilars.pdf. Accessed August 25, 2014.
   Google Scholar
• Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11(7):527–540.
   PubMed Web of Science ®Google Scholar
• Reddy S, Balamuralidhara V, Pramod Kumar TM, et al. Regulatory strategies for biosimilars in regulated and emerging markets. Pharma Times. 2013;45(1):11–14.
   Google Scholar
• PMDA. Recent regulations of biosimilars in Japan. [webpage on the Internet] PMDA; 2011. Available at: http://www.pmda.go.jp/regulatory/file/english_presentation/biologics/B-E1arato.pdf. Accessed August 25, 2014.
   Google Scholar
• Guidelines for the Quality, Safety and Efficacy Assurance of Follow-On Biologics [webpage on the Internet]; MHLW: Japan, 2009. Available at: http://www.pmda.go.jp/english/service/pdf/notifications/PFSB-ELD-0304007.pdf. Accessed August 25, 2014.
   Google Scholar
• Ando Y, Tominaga T, Kondo T. PMDA update: the current situation and future directions. GaBI J. 2013;2(1):41–44.
   Google Scholar
• Horikawa H, Tsubouchi M, Kawakami K. Industry views of biosimilar development in Japan. Health Policy. 2009;91(2):189–194.
   PubMed Web of Science ®Google Scholar
• Suh SK, Park Y. Regulatory guideline for biosimilar products in Korea. Biologicals. 2011;39(5):336–338.
   PubMed Web of Science ®Google Scholar
• Werble C. Canadian Biosimilar Approvals for Remicade: Time to Restart the Bus [webpage on the Internet]? 2014. Available at: http://pharmamedtechbi.com/publications/rpm-report/first-take/2014/1/canadian-biosimilar-approvals-for-remicade. Accessed August 25, 2014.
   Google Scholar
• Health Canada. Subsequent entry biologics approved in Canada [webpage on the Internet]. Health Canada; 2014. Available at: http://www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada. Accessed August 25, 2014.
   Google Scholar
• Kuhrt K, Gilpatrick J. A report from CPhI Worldwide 2013, Fifth Annual Pre-Connect Conference (October 22–24, 2013 – Frankfurt, Germany). Drugs Today (Barc). 2013;49(11):745–750.
   Web of Science ®Google Scholar
• Hadavand N, Valadkhani M, Zarbakhsh A. Current regulatory and scientific considerations for approving biosimilars in Iran. Biologicals. 2011;39(5):325–327.
   Web of Science ®Google Scholar
• Cheragalli AM. Current status of biopharmaceuticals in Iran’s pharmaceutical market. GaBI J. 2013;2(1):26–29.
   Google Scholar
• Haddadin RD. Concept of biosimilar products in Jordan. Biologicals. 2011;39(5):333–335.
   Web of Science ®Google Scholar
• Jordan Food and Drug Administration. Guidance for registration of biosimilars [webpage on the Internet]. Available at: http://www.jfda.jo/Download/News/239_530.pdf. Accessed August 25, 2014.
   Google Scholar
• Bohlega S, Al-Shammri S, Al Sharoqi I, et al. Biosimilars: opinion of an expert panel in the Middle East. Curr Med Res Opin. 2008; 24(10):2897–2903.
   PubMed Web of Science ®Google Scholar
• Edwards C. Generics, Supergenerics and Patent Strategies – SMi’s 13th Annual Meeting. IDrugs. 2010;13(7):433–436.
   Google Scholar
• Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29(4):310–312.
   PubMed Web of Science ®Google Scholar
• International nonproprietary names (INN) for biological and biotechnological substances [webpage on the Internet]. 2006. Available at: http://www.who.int/medicines/services/inn/BioRevforweb.pdf. Accessed August 25, 2014.
   Google Scholar
• The INN crowd. Nature biotechnology. 2013;31(12):1055.
   Web of Science ®Google Scholar
• PhRMA Comments to Generic Pharmaceutical Association Citizen. Petition Docket No FDA-2013-P-1153 [webpage on the Internet]. 2014. Food and Drug Administration. Available at: http://www.fdanews.com/ext/resources/files/02/02-03-14-PhRMA-Comments.pdf. Accessed August 25, 2014.
   Google Scholar
• Amgen Inc. Amgen supports World Health Organization’s proposed distinguishable naming policy for biosimilars [press release]. Thousand Oaks, CA: Amgen Inc.; 2013 [March 24]. Available from: http://www.amgen.com/media/amgen_statement_WHO_biosimilar_naming.html. Accessed August 25, 2014.
   Google Scholar
• Ebbers HC, Chamberlain P. Interchangeability An insurmountable fifth hurdle? GaBI J. 2014;3(2):88–94.
   Google Scholar
• France to allow biosimilars substitution [webpage on the Internet]. 2014. Available at: http://www.gabionline.net/Policies-Legislation/France-to-allow-biosimilars-substitution/(highlight)/france%20substitution. Accessed August 25, 2014.
   Google Scholar
• Naming and interchangeability of biosimilars raised in new survey [webpage on the Internet]. 2012. Available at: http://www.gabionline.net/Biosimilars/General/Naming-and-interchangeability-of-biosimilars-raised-in-new-survey. Accessed August 25, 2014.
   Google Scholar
• Dolinar R. It’s all about the name: what is the imperative of adopting a unique names for biologic and biosimilar therapeutics [webpage on the Internet]? Food Drug Pol Forum. 2012;2(22). Available at: http://safebiologics.org/pdf/fdli-asbm-its-all-about-the-name.pdf. Accessed August 25, 2014.
   Google Scholar