Drug and Medication in United States: Biosilimars: Obama Unfolds New Opportunities

• Publication date: April 2009

Opportunities 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 firms , looking to capitalise on patent expiries for complex and often cost...

Opportunities 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 firms , 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 industry : 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 industry are far from developed in some major industry s, 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 industry 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 industry – the US.

Drug And Medication Industry in South America

Biosimilars: Opportunities For Growth ... 5
chart: Magnitudes Of Complexity ..5
Interferon Beta And Associated Small Molecules
Difficult By Nature ... 6
Structural Complexities. 6
Data : Size Comparisons: Small Molecule Drugs Vs Biologicals...6
small molecule: Glucophage (metformin), Prozac (fluoxetine), Zantac (ranitidine),
Paxil (paroxetine), Claritin (loratadine), Zocor (simvastatin), Augmentin (co-amoxiclav),
Crixivan (indinavir), Taxol (paclitaxel)
Costs Of Development. 7
Regulatory & Industry Developments ... 8
European Union..8
chart: EMEA Initial Evaluations By Type Of Application..8
2005 - 2007
Country Specific Guidelines 9
Data : selected biosimilar product appraisals by the european medicines agency9
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..9
Legislative Proposals.. 10
Data : Proposed Industry ing Exclusivity Years From Date Of Patent Application.10
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...11
Obama Initiatives.11
chart: Inflated? .11
Average Annual % Change In US Manufacturer Prices Of Pharmaceuticals
Japan11
chart: Pharmaceuticals & Medical Devices Agency (PDMA) ..12
Median Approval Time For New Drugs In Japan (Months)
Canada.12
India 12
China13
South Korea..13
Thailand...13
The Middle East.13
Others...14
Unprotected Biologics ... 15
Erythropoietin (EPO) . 15
Data : key biologic patent expires..15
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) ..16
Market Share By Brand MAT June 2006
Recombinant Human Insulin.. 16
chart: Recombinant Human Insulin.16
Market Share By Brand MAT June 2006
Interferon beta 17
chart: Interferon beta 17
Market Share By Brand MAT June 2006
Granulocyte-Colony Stimulating Factor (G-CSF) 17
chart: G-CSF ..17
Market Share By Brand MAT June 2006
Human Growth Hormone (hGH). 18
chart: hGH .18
Market Share By Brand MAT June 2006
chart: US Omnitrope (somatropin) Sales (US$mn)..18
Q107 - Q208
Interferon Alfa. 18
chart: Interferon Alfa 18
Market Share By Brand MAT June 2006
Market Opportunities 20
Biotech Boom. 20
chart: World Prescription Industry Fo recast ...20
Small Molecule Drugs Vs Biologics
chart: Sales Of Biotechnology Products By Region20
2003 vs 2007
Penetration Factors 21
chart: Regional Breakdown Of Biotechnology & Prescription Drug Sales .21
2007
chart: Pharmaceutical Industry s With Highest Generic Industry Share* .21
2008
chart: Pharmaceutical Industry s With Lo west Generic Industry Share* ..22
2008
Pricing Issues. 22
Data : USTR Special 301 2008 - Countries With Noted Pharmaceutical IP Issues..22
priority watch list: China, Russia, Argentina, Chile, India, Israel, Pakistan, Venezuela
Adding Value.. 22
Company Developments ... 24
Western Manufacturers.. 24
Emerging Industry Drugmakers 25
Outlook .. 26
References . 27