Economic Analysis of Availability of Follow-on Protein Products. Appendix C: Specific Biologics in Six Major Categories C-1

07/27/2009

 

Table C-1: Specific Biologics in Six Major Categories
 Drug Name    Sales ($M)1    US Market Share    US Patent Expiration  US/EU Approved Biosimilar(s)    Biosimilars approved in other countries or under development    Within-category Ranking***    Pros    Cons  
 EPO  
 Aranesp    $4,121    38.8% 2    2016 4    No    No    2    Largest sales Largest market share Biosimilar approved in China    Later patent expiration Offers a marginal/insignificant clinical improvement over Procrit/EPOGEN  
 Procrit/EPOGEN    $3,180 (Procrit) $2,844 (EPOGEN)    29.2% (Procrit) 32% (EPOGEN) 2    2013 4    Yes 9    Yes: China 10 *    1    Large sales Large market share Biosimilar approved in EU Biosimilar approved in China    
 Neorecormon/Epogin    $1,794    Not marketed in US    No    N/A    N/A    N/A    N/A    
 MAbs  
 Rituxan    $3,912    Not available    2015 4 **    No    In development: India 10    1    Largest sales in category Third overall in the top 20 biologics by sales 2006 Biosimilar in development in India    
 Herceptin    $3,175    Not available    2015 4    No    In development: India 10    2    Second largest sales in category Sixth overall in the top 20 biologics by sales 2006 Biosimilar in development in India    
 Avastin    $2,395    Not available    2017 4 **    No    No    3    Large sales Tenth overall in the top 20 biologics by sales 2006    No biosimilar in development Late patent expiration  
 Anti-TNF  
 Enbrel    $4,474    Not available    2012 4    No    Yes: China 11    1    Largest sales in category First overall in the top 20 biologics by sales 2006 Biosimilar already approved in China    
 Remicade    $3,764    Not available    2014 5    No    No    2    Second largest sales in category 4th overall in the top 20 biologics by sales 2006 Patent expires in five years    No biosimilar in development Uses MAb technology that may bepatent protected until 2018  
 Humira    $2,044    Not available    2016 4 **    No    No    3    Large sales Twelfth overall in the top 20 biologics by sales 2006    No biosimilar in development Late patent expiration Uses MAb technology that may bepatent protected until 2018  
 Interferon beta  
 Avonex    $1,707    39.5% 2    2013 4    No    No    1    Largest sales in category Largest US market share in category Patent expires in four years Fifteenth overall in the top 20 biologics by sales 2006    No biosimilar in development  
 Rebif    $1,418    14.3% 2    2013 4    No    No    2    Second largest sales in category Sixteenth overall in the top 20 biologics by sales 2006 Patent expires in four years    No biosimilar in development  
 Betaseron    $1,273    14.3% 2    2007/2008 2,6,7,8    No    No    3    Large sales Patent has already expired Nineteenth overall in the top 20 biologics by sales 2006    No biosimilar in development  
 G-CSF  
 Neulasta    $2,710    51% (global) 3    2015 4    No    Yes: Lithuania 10 Pending approval: marketing rights for Europe and the rest of the world with the exception of Japan and US 10 In development in the EU: Phase 1-2a study 10    2    Largest sales in category Large market share Eighth overall in the top 20 biologics by sales 2006 Biosimilar approved in Lithuania and pending approval the rest of the world except Japan and the US In phase 1-2a studies in EU    Later patent expiration Offers a marginal/insignificant clinical improvement over Neupogen  
 Neupogen    $1,213    24% (global) 3    2013 4    Yes 9,13,14,15,16,17,18    In development for: Europe, South-Eastern Asia, Middle East, Asia Pacific - Phase 3 10    1    Large sales Patent expires in four years Seventeenth overall in the top 20 biologics by sales 2006 Biosimilar in phase 3 trials for EU and other parts of the world    Second generation peglated product has taken large portion ofmarket share  
 Interferon alpha  
 Pegasys    $1,186    Not available   2017 4    No    Yes: China 10 In development: EU 10    1    Large sales Biosimilar product in development for EU use by Biopartners Biosimilar already developed in China by Shenzhen Kexing Biotech Significant clinical advantage over non-pegylated interferon alpha Pegylation increases safety, efficacy, and duration of effect 12 Less frequent dosing increases odds of compliance 12    Shrinking market with the decline in hepatitis A incidence  

Sources

1 Top 20 biologics. Barcelona, Spain: La Merie Business Intelligence, 2007. Accessed November 16, 2007. http://www.pipelinereview.com/free-downloads/Top20Biologics2006.pdf

2 Miller S, Houts J. Potential savings of biogenerics in the United States. Express Scripts, 2007
3 Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: evolution or revolution for generics companies? PriceWaterhouseCoopers LLP, 2007.
4 Riley S. The pharmaceutical market outlook to 2018 London, UK: Reuters Business Insights, 2008.
5 Lanthier M, Behrman R, Nardinelli C. Economic issues with follow-on protein products. Nature Reviews Drug Discovery, 2008: e-pub 25 July, 2008.
6 Schering AG: set for Betaseron buy-back boost. Pharmaceutical Business Review Online, 2006. Accessed January 4, 2008. http://www.pharmaceutical-business-review.com/articlefeature.asp?guid=754ADB1D-F6AC-4FAF-9781-B00AD97D8941.
7 Biotech feature (Issue 2): biogenerics. PipelineReview.com. Accessed January 4, 2008. http://www.pipelinereview.com/pipelinesamples/biogenericsbfm.pdf.
8 Patent Terms Extended Under 35 USC §156. Washington, DC: United States Patent and Trademark Office, 2007. Accessed January 18, 2008. http://www.uspto.gov/web/offices/pac/dapp/opla/term/156.html.
9 Zuhn D. Three new biosimilars pass EMEA test. Patent Docs: Biotech & Pharma Patent Law and News Blog, 2007. http://www.patentdocs.net/patentdocs/2007/07/three-new-biosi.html.
10 The future of biosimilars: key opportunities and emerging therapies. London, UK: Reuters Business Insights, 2007.
11 Pearson S. Biosimilars market ripe for expansion: can innovation in drug design stem the rising tide? Generic Engineering and Biotechnology News 2007;27(9). http://www.genengnews.com/articles/chitem.aspx?aid=2115&chid=4
12 Searcy C. How advanced drug delivery technologies can help manage product life cycles throughout pharmaceutical development. Montville, NJ: Drug Delivery Technologies. Accessed January 18, 2008. http://www.drugdeliverytech.com/cgibin/
articles.cgi?idArticle=206.
13: EPARs for authorised medicinal products for human use: Biograstim. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/biograstim/biograstim.htm
14: EPARs for authorised medicinal products for human use: Filgrastim Ratiopharm. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/filgrastimratiopharm/filgrastimratiopharm.htm
15: EPARs for authorised medicinal products for human use: Ratiograstim. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/ratiograstim/ratiograstim.htm
16: EPARs for authorised medicinal products for human use: Tevagrastim. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/tevagrastim/tevagrastim.htm
17: EPARs for authorised medicinal products for human use: Filgrastim Hexal. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/filgrastimhexal/filgrastimhexal.htm
18: EPARs for authorised medicinal products for human use: Zarzio. London, England: European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/zarzio/zarzio.htm

*India has a biosimilar EPO but it is unclear which brand drug it replicates **Genentech received a patent in 2001 for Cabilly II, a combination of Cabilly and Boss technologies, and as a result, now holds the technology that nearly all companies planning to manufacture recombinant monoclonal antibodies must license. The patent for Cabilly II originally did not expire until 2018 but after a patent challenge, the US government revoked the patent. Genentech has appealed this decision and the patent remains valid and enforceable throughout the appeals process. Source: Rader RA. Biopharmaceutical products in the U.S. and European markets. BioPlan Associates, Inc., 2007 & Pollack, A. Patent held by Genentech is revoked by government. The New York Times, February 22, 2007. Accessed January 18, 2008. http://www.nytimes.com/2007/02/22/business/22patent.html?r=1&oref=slogin

*** Within Category Ranking denotes the likelyhood of a FoPP for aparticular product within the drug class. We use this ranking to determine the specific candidate biologics for our analysis

 

View full report

Preview
Download

"report.pdf" (pdf, 575.91Kb)

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®