The document outlines the timeline of biosimilars pathways, detailing significant regulatory developments from the European Medicines Agency (EMA) and global entities. Key milestones include the publication of guidelines for biosimilars by the EMA, the approval of various biosimilars in Europe, the U.S., Canada, and Japan, and the enactment of the Biologics Price Competition and Innovation Act. It highlights the increasing regulatory frameworks designed to ensure the quality and efficacy of biosimilars since the mid-2000s.

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FDA issues Draft Guidance Document on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.
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www.biolink.us Biosimilars Timeline