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Biosimilar Analysis
Biological Patent Expiries
Biosimilars are expected to increasingly challenge
branded biologicals in coming years
Total of $87.4 billion of branded biological sales
at patent risk from this year to 2020
Eli Lilly’s insulin glargine recombinant forecasted
to be top selling biosimilar in 2020 at $631 mln
First Approvals
Sales of Biologicals Going Off Patent
BiologicalProductSales
atRisk$(mln)
0
5,000
10,000
15,000
20,000
25,000
2014
7,692
2015
10,183
2016
22,957
HUMIRA,LANTUS
2017
4,701
2018
17,899
2019
23,289
2020
713
RITUXAN,REMICADE
AVASTIN,HERCEPTIN
1st EU Biosimilar
2006Omnitrope - Sandoz
Somatotropin biosimilar approved
by the EMA on the 12th of April 2006
1st USA Biosimilar
2015Zarxio - Sandoz
Biosimilar filgrastim approved
by the FDA on the 6th March 2015
1st Japan Biosimilar
2009Omnitrope - Sandoz
Somatotropin biosimilar approved
by the MHLW on the 22nd of June 2009
Count of Biosimilars Approved in Europe, Japan and USA
Pricing: Comparing Biosimiliars and Branded Products
How Will Biosimilars be Priced Compared to Branded Biologicals?
Case study using reimbursed NHI drug prices
0
1
2
3
4
5
6
2006
1
2007
5
2008
3
2009
2
1
2010
1 1
2011 2012
2
2013
4
2
2014
3
2
2015
1
EMA Japan FDA
Europe is the market
with the most
approved
biosimilars -19
9separate branded
biologicals targeted
in Europe.
MHLW in Japan has
approved biosimilars of
different branded
biologicals.
Just one approved
biosimilar in the
Biosimilars on the
market since:
Historically, biosimilars
targeting biological
products have launched in
Europe first
Count of EMA, MHLW and FDA approved biosimilars by year
© Copyright 2015 Evaluate Ltd. All rights reserved.
The reimbursement price
of Remicade is $750.32,
compared to $513.95 for
the biosimilar Remsima.
100mg I.V. for infusion.
The reimbursement price
of Neupogen is $197.28,
compared to $129.69 for
the biosimilar Filgrastim.
300µg syringe.
Remicade
$750.32
Neupogen
$197.28
$513.95
Remsima
$126.69
Filgrastim
32%: The price difference between the biological and branded equivalent in Japan for both products
USA- Zarxio
2006
Europe
2009
Japan
4
Evaluate Headquarters
Evaluate Ltd.
11-29 Fashion Street
London E1 6PX
United Kingdom
T +44 (0)20 7377 0800
F +44 (0)20 7539 1801
Evaluate North America
EvaluatePharma USA Inc.
15 Broad Street, Suite 401
Boston, MA 02109, USA
T +1 617 573 9450
F +1 617 573 9542
Evaluate Japan
EvaluatePharma Japan K.K.
Kyodo Tsushin Kaikan 2F
2-2-5 Toranomon Minato-ku
Tokyo 105-0001, Japan
T +81 (0)80 1164 4754
www.evaluate.com
To learn more about EvaluatePharma®
please request a demo: www.evaluategroup.com/ContactUs
Established in 1996, Evaluate Ltd is the trusted leader in high quality life
science sector analysis and consensus forecasts to 2020. Evaluate’s
team of expert analysts transform life science information into insights
so companies can perform well.
EvaluatePharma®
delivers exclusive consensus sales forecasts and
trusted commercial insight into biotech and pharmaceutical performance.
@EvaluatePharma
EvaluateMedTech®
sets a new standard in commercial analysis and
consensus forecasts of the global medical device and diagnostic industry.
@EvaluateMedTech
EvaluateClinical Trials®
delivers unique clinical trial intelligence expertly
curated to efficiently analyse the global clinical trial landscape.
@EPClinicalTrial
EP Vantage an award winning editorial team, provides daily commentary
and analysis with fresh perspectives and insight into current and future
industry trends.
@EPVantage
The Evaluate services enable the life science community to make sound
business decisions about value and opportunity.

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Evaluate Biosimilar Analysis Infographic

  • 1. Biosimilar Analysis Biological Patent Expiries Biosimilars are expected to increasingly challenge branded biologicals in coming years Total of $87.4 billion of branded biological sales at patent risk from this year to 2020 Eli Lilly’s insulin glargine recombinant forecasted to be top selling biosimilar in 2020 at $631 mln First Approvals Sales of Biologicals Going Off Patent BiologicalProductSales atRisk$(mln) 0 5,000 10,000 15,000 20,000 25,000 2014 7,692 2015 10,183 2016 22,957 HUMIRA,LANTUS 2017 4,701 2018 17,899 2019 23,289 2020 713 RITUXAN,REMICADE AVASTIN,HERCEPTIN 1st EU Biosimilar 2006Omnitrope - Sandoz Somatotropin biosimilar approved by the EMA on the 12th of April 2006 1st USA Biosimilar 2015Zarxio - Sandoz Biosimilar filgrastim approved by the FDA on the 6th March 2015 1st Japan Biosimilar 2009Omnitrope - Sandoz Somatotropin biosimilar approved by the MHLW on the 22nd of June 2009 Count of Biosimilars Approved in Europe, Japan and USA Pricing: Comparing Biosimiliars and Branded Products How Will Biosimilars be Priced Compared to Branded Biologicals? Case study using reimbursed NHI drug prices 0 1 2 3 4 5 6 2006 1 2007 5 2008 3 2009 2 1 2010 1 1 2011 2012 2 2013 4 2 2014 3 2 2015 1 EMA Japan FDA Europe is the market with the most approved biosimilars -19 9separate branded biologicals targeted in Europe. MHLW in Japan has approved biosimilars of different branded biologicals. Just one approved biosimilar in the Biosimilars on the market since: Historically, biosimilars targeting biological products have launched in Europe first Count of EMA, MHLW and FDA approved biosimilars by year © Copyright 2015 Evaluate Ltd. All rights reserved. The reimbursement price of Remicade is $750.32, compared to $513.95 for the biosimilar Remsima. 100mg I.V. for infusion. The reimbursement price of Neupogen is $197.28, compared to $129.69 for the biosimilar Filgrastim. 300µg syringe. Remicade $750.32 Neupogen $197.28 $513.95 Remsima $126.69 Filgrastim 32%: The price difference between the biological and branded equivalent in Japan for both products USA- Zarxio 2006 Europe 2009 Japan 4
  • 2. Evaluate Headquarters Evaluate Ltd. 11-29 Fashion Street London E1 6PX United Kingdom T +44 (0)20 7377 0800 F +44 (0)20 7539 1801 Evaluate North America EvaluatePharma USA Inc. 15 Broad Street, Suite 401 Boston, MA 02109, USA T +1 617 573 9450 F +1 617 573 9542 Evaluate Japan EvaluatePharma Japan K.K. Kyodo Tsushin Kaikan 2F 2-2-5 Toranomon Minato-ku Tokyo 105-0001, Japan T +81 (0)80 1164 4754 www.evaluate.com To learn more about EvaluatePharma® please request a demo: www.evaluategroup.com/ContactUs Established in 1996, Evaluate Ltd is the trusted leader in high quality life science sector analysis and consensus forecasts to 2020. Evaluate’s team of expert analysts transform life science information into insights so companies can perform well. EvaluatePharma® delivers exclusive consensus sales forecasts and trusted commercial insight into biotech and pharmaceutical performance. @EvaluatePharma EvaluateMedTech® sets a new standard in commercial analysis and consensus forecasts of the global medical device and diagnostic industry. @EvaluateMedTech EvaluateClinical Trials® delivers unique clinical trial intelligence expertly curated to efficiently analyse the global clinical trial landscape. @EPClinicalTrial EP Vantage an award winning editorial team, provides daily commentary and analysis with fresh perspectives and insight into current and future industry trends. @EPVantage The Evaluate services enable the life science community to make sound business decisions about value and opportunity.