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FDA issues Draft Guidance Document on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 onlineGenerics 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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