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Published by: Business Monitor International
Published: Apr. 6, 2009 - 28 Pages
Table of Contents
- Biosimilars: Opportunities For Growth
- chart: Magnitudes Of Complexity
- Interferon Beta And Associated Small Molecules
- Difficult By Nature
- Structural Complexities
- Table: Size Comparisons: Small Molecule Drugs Vs Biologicals
- small molecule: Glucophage (metformin), Prozac (fluoxetine), Zantac (ranitidine),
- Paxil (paroxetine), Claritin (loratadine), Zocor (simvastatin), Augmentin (co-amoxiclav),
- Crixivan (indinavir), Taxol (paclitaxel)
- Costs Of Development
- Regulatory & Market Developments
- European Union
- chart: EMEA Initial Evaluations By Type Of Application
- 2005 - 2007
- Country Specific Guidelines
- Table: selected biosimilar product appraisals by the european medicines agency
- trade name: omnitrope, valtropin, alpheon, abseamed, binocrit, epoetin alfa hexal,
- retacrit, silapo, insulin rapid marvel, long marvel, 30,70 mix marvel, ratiograstim,
- biogratim, tevagrastim, filgrastim hexal4, zarzio, biferonex
- United States
- Legislative Proposals
- Table: Proposed Marketing Exclusivity Years From Date Of Patent Application
- drug type: Years between patent application and fda approval of brand drug,
- gatt non-drugs, hatch-waxman chemical drugs, waxman biologics bill, kennedy biologics
- bill, eshoo-barton bill, inslee biologics bill
- Economic Benefits
- Obama Initiatives
- chart: Inflated?
- Average Annual % Change In US Manufacturer Prices Of Pharmaceuticals
- Japan
- chart: Pharmaceuticals & Medical Devices Agency (PDMA)
- Median Approval Time For New Drugs In Japan (Months)
- Canada
- India
- China
- South Korea
- Thailand
- The Middle East
- Others
- Unprotected Biologics
- Erythropoietin (EPO)
- Table: key biologic patent expires
- name of biological product: Cerezyme/Ceredase (alglucerase), Humulin (human insulin),
- Intron A (interferon alpha-2b), Avonex (interferon beta-1a), Humatrope (somatropin),
- Genotropin (somatropin), Betaseron (interferon beta-1b), Nutropin (somatropin), Epogen/
- Procrit (epoetin alfa), Recormon (epoetin beta), Novolin (human insulin), Activase (alteplase),
- Protopin (somatrem), Neupogen (filgrastim), Engerix-B (heaptitis B vaccine), Filgrastim (GM-CSF)
- chart: Erythropoietin (EPO)
- Market Share By Brand MAT June 2006
- Recombinant Human Insulin
- chart: Recombinant Human Insulin
- Market Share By Brand MAT June 2006
- Interferon beta
- chart: Interferon beta
- Market Share By Brand MAT June 2006
- Granulocyte-Colony Stimulating Factor (G-CSF)
- chart: G-CSF
- Market Share By Brand MAT June 2006
- Human Growth Hormone (hGH)
- chart: hGH
- Market Share By Brand MAT June 2006
- chart: US Omnitrope (somatropin) Sales (US$mn)
- Q107 - Q208
- Interferon Alfa
- chart: Interferon Alfa
- Market Share By Brand MAT June 2006
- Market Opportunities
- Biotech Boom
- chart: Global Prescription Market Fo recast
- Small Molecule Drugs Vs Biologics
- chart: Sales Of Biotechnology Products By Region
- 2003 vs 2007
- Penetration Factors
- chart: Regional Breakdown Of Biotechnology & Prescription Drug Sales
- 2007
- chart: Pharmaceutical Markets With Highest Generic Market Share*
- 2008
- chart: Pharmaceutical Markets With Lo west Generic Market Share*
- 2008
- Pricing Issues
- Table: USTR Special 301 2008 - Countries With Noted Pharmaceutical IP Issues
- priority watch list: China, Russia, Argentina, Chile, India, Israel, Pakistan, Venezuela
- Adding Value
- Company Developments
- Western Manufacturers
- Emerging Market Drugmakers
- Outlook
- References
AbstractOpportunities bestowed by the successful launch of follow-on biologic products are being seized upon. Unlike their traditional generic counterparts, which are generally sold using a business model of high volume but low margins, biosimilars represent a much higher return on investment for developers. This potential is being investigated by a number of major pharmaceutical companies, looking to capitalise on patent expiries for complex and often costly biological products.
Two different approaches may be used in attempting to bring biosimilars to market: to simply mimic the action of the reference product, or to redevelop biologics and provide innovative modifications. These options offer differing complexities and broader ranges of potential returns.
Despite the plethora of potential options borne out by a growing number of patent expiries, the pathways for bringing biosimilars to market are far from developed in some major markets, including the US. Meanwhile others such as the EU have been progressive in giving patients access to follow-on products. As a result there remains large variability in the market for biosimilars.
In this report, Biosimilars: Obama Unfolds New Opportunities, BMI explores the current attractions and opportunities in manufacturing follow-on biologics on a global scale, including President Obama’s push towards lowering healthcare costs and its potential effect on facilitating entry into the world’s largest biologics market - the US.
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