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Timeline of Biosimilars Pathways

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The biosimilars frontier is still a fairly new market, but its regulatory beginnings can be traced back to the early 2000s, with Europe, Asia and Australia among the early adopters. See the attached document for a look at the global progress of biosimilars.

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Timeline of Biosimilars Pathways

  1. 1. Timeline of Biosimilars Pathways The EMA and European Commission (EC) drafts then publishes the Guideline on similar biological medicinal products, the first regulatory pathway and framework for the marketing authorization of biosimilars – setting the benchmark with its stringent guidelines for this new biopharmaceutical arena. Europe approves the first biosimilar, Omnitrope (somatropin) for sale. Australia adopts unaltered EMA’s EU biosimilar guidelines, but amends them in 2013. The enacted Patient Protection and Affordable Care Act (AKA Obamacare) paves the way for FDA approval of biosimilars and interchangeables. EU releases first revision to its 2005 guidelines. European Medicines Agency (EMA) opens the pathway, publishing the first directive, which outlined the differences in the raw materials and manufacture of reference products and biosimilars. First Biologics Price Competition and Innovation Bill 2007 introduced to US Congress by then Senator (the late) Edward Kennedy. -World Health Organization publishes a guideline for biosimilar standards, to be globally recognized. -Biologics Price Competition and Innovation Act passed by US Congress, signed into law the following year as part of Obamacare. -Canada approves its first biosimilar, Omnitrope (somatropin) for sale, and Health Canada finalizes its own regulatory guidelines the next year. -Japan releases its biosimilar regulatory guidelines, based on the EU guidelines, in March and approves its first biosimilar, Somatropin, in June. FDA issues Draft Guidance Document on Biosimilars, establishing requirements needed to demonstrate the comparability of biosimilars to their reference products. In March, USA approves first biosimilar, Zarxio (filgrastim). Second revised EU guidelines are due for release on 30 April 2015. 2001 2006 2008 2010 2013 2005 2007 2007 2012 2015 Biosimilarnews.com. EMA published the revised biosimilars guideline. 2014. Available at: http://www.biosimilarnews.com/emapublishedtherevisedbiosimilars- guideline. Accessed April 27, 2015. Biosimilar Medicinal Products. 1st ed. London: European Medicines Agency; 2013:5. Guideline On Similar Biological Medicinal Products. 1st ed. London: European Medicines Agency; 2014:7. Guideline On Similar Biological Medicinal Products Containing Biotechnology Dervied Proteins As Active Substance: NonClinical And Clinical Issues. 1st ed. London: European Medicines Agency; 2006:8. Zwebb h. Biosimilars approved in Europe / General / Biosimilars / Home GaBI online Generics and Biosimilars Initiative. Gabionlinenet. 2015. Available at: http://www.gabionline.net/Biosimilars/General/BiosimilarsapprovedinEurope. Accessed April 27, 2015. Biosimilarnews.com. Australian Biosimilars Guideline. 2011. Available at: http://www.biosimilarnews.com/australianbiosimilarsguideline. Accessed April 27, 2015. Therapeutic Goods Administration (TGA). Multidisciplinary guidelines. 2015. Available at: https://www.tga.gov.au/multidisciplinaryguidelines#biosimilars. Accessed April 27, 2015. Ihs.com. Australia's TGA updates biosimilars guidelines. 2013. Available at: https://www.ihs.com/country-industryforecasting.html?ID=1065982432. Accessed April 27, 2015. Zwebb. WHO guidelines on biosimilars: case studies and discussion highlights / Reports / Home GaBI online Generics and Biosimilars Initiative. Gabionlinenet. 2012. Available at: http://www.gabionline.net/Reports/WHOguidelinesonbiosimilarscasestudiesand- discussionhighlights. Accessed April 27, 2015. GovTrack.us. Biologics Price Competition and Innovation Act of 2007 (2007 S. 1695). 2007. Available at: https://www.govtrack.us/congress/bills/110/s1695. Accessed April 27, 2015. Zwebb. Subsequent entry biologics approved in Canada / General / Biosimilars / Home GaBI online Generics and Biosimilars Initiative. Gabionlinenet. 2014. Available at: http://www.gabionline.net/Biosimilars/General/Subsequententry- biologicsapprovedinCanada. Accessed April 27, 2015. Sandoz.com. SANDOZ RECEIVES APPROVAL FOR FIRSTEVER JAPANESE BIOSIMILAR. 2009. Available at: http://www.sandoz.com/media_center/ press_releases_news/global_news/sandoz_receives_approval_for_first- ever_japanese_biosimilar.shtml. Accessed April 27, 2015. 1 2 3 4 5 6 7 8 9 10 11 12 www.biolink.us Biosimilars Timeline

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