BiosimilarsBiosimilars
… the Growth Opportunities… the Growth Opportunities
By-
Swati Varma
MBA-BT
IMED
BiopharmaceuticalsBiopharmaceuticals
Biopharmaceuticals can be termed as medicalBiopharmaceuticals can be termed as medica...
The distinct families ofThe distinct families of
Biopharmaceuticals includes:Biopharmaceuticals includes:
Hormones and enz...
BiologicalsBiologicals Conventional DrugsConventional Drugs
Mol. SizeMol. Size 50005000--200,000 Daltons200,000 Daltons 10...
Facts & FiguresFacts & Figures
In 2009, global revenues of Biologicals were aroundIn 2009, global revenues of Biologicals ...
Examples of genetically engineeredExamples of genetically engineered
recombinant proteins used in Medicines:recombinant pr...
Top 20 biopharmaceutical drugsTop 20 biopharmaceutical drugs
Drug nameDrug name IndicationIndication Revenue (2008)Revenue...
11.Prevnar (Wyeth)11.Prevnar (Wyeth) Prevention byPrevention by
S.pneumoniaS.pneumonia
$ 2,716$ 2,716
12. Taxotere (sanofi...
BIOSIMILARSBIOSIMILARS
BIOGENERICSBIOGENERICS
FOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIO...
BiosimilarsBiosimilars
Biosimilars are the equivalent of generics forBiosimilars are the equivalent of generics for
Biolog...
Difference between Small molecule Generics & BiosimilarsDifference between Small molecule Generics & Biosimilars
Market advantageMarket advantage
Blockbuster Biotech InnovatorBlockbuster Biotech Innovator
drugs to go off patent.drugs t...
300
400
500
600
700
800
900
1
2
3
4
Global Markets for Biosimilars by type ($ US million)
0
100
200
300
2008 2009
4
1= Rec...
Global Markets for Biosimilars by disease ($ US Million)Global Markets for Biosimilars by disease ($ US Million)
200
300
4...
Regulatory statusRegulatory status
Owning to the complex natureOwning to the complex nature
of Biologicals, strict testing...
BIOSIMILARS : On the Brink of Accelerated Growth
Prediction of biosimilar sales by product in seven major markets (France,...
Biosimilars in INDIABiosimilars in INDIA
Dr. Reddy's and Biocon both brought biosimilar versionsDr. Reddy's and Biocon bot...
Key Players in IndiaKey Players in India
Dr. ReddysDr. Reddys
BioconBiocon
Intas BiopharmaceuticalsIntas Biopharmaceutical...
Challenges for BiosimilarsChallenges for Biosimilars
BiosimilarBiosimilar isis “similar”“similar” andand nono “generic”“ge...
That’s all…That’s all…
THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THA...
Biosimilars
Biosimilars
Biosimilars
Biosimilars
Biosimilars
Upcoming SlideShare
Loading in...5
×

Biosimilars

14,632

Published on

Basic Information of Biosimilars. This ppt is basd on secondary data by various internet sites.

For downloading, send me an e-mail.

Published in: Education, Business, Technology
23 Comments
31 Likes
Statistics
Notes
No Downloads
Views
Total Views
14,632
On Slideshare
0
From Embeds
0
Number of Embeds
5
Actions
Shares
0
Downloads
1
Comments
23
Likes
31
Embeds 0
No embeds

No notes for slide

Biosimilars

  1. 1. BiosimilarsBiosimilars … the Growth Opportunities… the Growth Opportunities By- Swati Varma MBA-BT IMED
  2. 2. BiopharmaceuticalsBiopharmaceuticals Biopharmaceuticals can be termed as medicalBiopharmaceuticals can be termed as medical drugs made through biotechnology.drugs made through biotechnology. These are therapeutic or preventive medicinesThese are therapeutic or preventive medicines derived from cells using rderived from cells using r--DNA technology.DNA technology.derived from cells using rderived from cells using r--DNA technology.DNA technology. First such substance approved for therapeuticFirst such substance approved for therapeutic use was biosyntheticuse was biosynthetic Human insulinHuman insulin made bymade by rDNA technology.rDNA technology.
  3. 3. The distinct families ofThe distinct families of Biopharmaceuticals includes:Biopharmaceuticals includes: Hormones and enzymesHormones and enzymes Cytokines and peptideCytokines and peptide VaccinesVaccines Monoclonal AntibodiesMonoclonal Antibodies Antisense drugsAntisense drugs Cell therapiesCell therapies
  4. 4. BiologicalsBiologicals Conventional DrugsConventional Drugs Mol. SizeMol. Size 50005000--200,000 Daltons200,000 Daltons 1010--1000 Daltons1000 Daltons Mol. StructureMol. Structure Exhibit complex spatialExhibit complex spatial structures, which arestructures, which are difficult to determinedifficult to determine Simpler spatial structure, easilySimpler spatial structure, easily determined thru analyticaldetermined thru analytical tech.tech. ComplexityComplexity Complex ingredientsComplex ingredients (impurities, leachables,(impurities, leachables, excipients, byexcipients, by--product etc)product etc) Relatively pure componentsRelatively pure components ClinicalClinical BehaviourBehaviour Complicated modes of actionComplicated modes of action Well understood mode of actionWell understood mode of action ManufacturingManufacturing ProcessProcess Specific & ComplexSpecific & Complex biological processbiological process Chemical synthesisChemical synthesis Batch to batchBatch to batch variationvariation No 2 batches will be entirelyNo 2 batches will be entirely identicalidentical Small to negligible variationsSmall to negligible variations ManufacturingManufacturing costcost HighHigh Relatively lowRelatively low
  5. 5. Facts & FiguresFacts & Figures In 2009, global revenues of Biologicals were aroundIn 2009, global revenues of Biologicals were around $125 billion.$125 billion. More than 200 biologicals are already in market.More than 200 biologicals are already in market. 25% of the pipeline drugs are Biologicals25% of the pipeline drugs are Biologicals It is estimated, by 2014 out of top 10 drugs 7 would be ofIt is estimated, by 2014 out of top 10 drugs 7 would be of biological in origin.biological in origin. Biosimilars are going to be the next big thing in globalBiosimilars are going to be the next big thing in global medicinal industry.medicinal industry.
  6. 6. Examples of genetically engineeredExamples of genetically engineered recombinant proteins used in Medicines:recombinant proteins used in Medicines: Recombinant ProteinRecombinant Protein Clinical applicationClinical application Growth HormoneGrowth Hormone Growth hormone deficiencyGrowth hormone deficiency Insulin like growth factor 1 (IGFInsulin like growth factor 1 (IGF--1)1) Growth disorders resistant toGrowth disorders resistant to growth hormonegrowth hormone InsulinInsulin Diabetes MellitusDiabetes Mellitus Follicle stimulating hormone (FSH)Follicle stimulating hormone (FSH) Ovulation InductionOvulation Induction
  7. 7. Top 20 biopharmaceutical drugsTop 20 biopharmaceutical drugs Drug nameDrug name IndicationIndication Revenue (2008)Revenue (2008) 1. Enbrel (Amgen)1. Enbrel (Amgen) Rheumatoid arthritis, ++Rheumatoid arthritis, ++ $5,982 M$5,982 M 2. Rituxan (Genentech)2. Rituxan (Genentech) NonNon--Hodgkin’sHodgkin’s lymphoma ++lymphoma ++ $5,082 M$5,082 M 3. Humira ( Abbott)3. Humira ( Abbott) Rheumatoid arthritis, ++Rheumatoid arthritis, ++ $4,521 M$4,521 M 4. Avastin (Genentech)4. Avastin (Genentech) Colorectal cancer ++Colorectal cancer ++ $4,479 M$4,479 M 5. Herceptin (Genentech5. Herceptin (Genentech Breast cancerBreast cancer $4,394 M$4,394 M 6. Remicade (J&J)6. Remicade (J&J) Crohn’s disease ++Crohn’s disease ++ $3,748 M$3,748 M 7. Gleevac (Novartis)7. Gleevac (Novartis) Chronic myelogenousChronic myelogenous leukemia ++leukemia ++ $3,700 M$3,700 M 8. Neulasta (Amgen)8. Neulasta (Amgen) InfectionsInfections $3,318 M$3,318 M 9. Lantus (Sanofi aventis9. Lantus (Sanofi aventis Type I & II diabetesType I & II diabetes $3,159 M$3,159 M 10. Aranesp (Amgen)10. Aranesp (Amgen) AnemiaAnemia $3,137 M$3,137 M
  8. 8. 11.Prevnar (Wyeth)11.Prevnar (Wyeth) Prevention byPrevention by S.pneumoniaS.pneumonia $ 2,716$ 2,716 12. Taxotere (sanofi)12. Taxotere (sanofi) Breast cancerBreast cancer $ 2,622$ 2,622 13. Procrit/ Eprex13. Procrit/ Eprex AnemiaAnemia $ 2,460$ 2,460 14. Epogen (Amgen)14. Epogen (Amgen) AnemiaAnemia $ 2,456$ 2,456 15. Copaxone (teva)15. Copaxone (teva) Multiple SclerosisMultiple Sclerosis $ 2,262$ 2,262 16. Avonex (Biogen Idec)16. Avonex (Biogen Idec) Multiple SclerosisMultiple Sclerosis $ 2.203$ 2.203 SourceSource-- Bioworld researchBioworld research 16. Avonex (Biogen Idec)16. Avonex (Biogen Idec) Multiple SclerosisMultiple Sclerosis $ 2.203$ 2.203 17. Truvada (Gilead)17. Truvada (Gilead) HIVHIV $ 2,110$ 2,110 18. Lucentis (Genentech)18. Lucentis (Genentech) Macular degenerationMacular degeneration $ 1,761$ 1,761 19. Humalog (Elii Lilly)19. Humalog (Elii Lilly) DiabetesDiabetes $ 1,736$ 1,736 20. Rebif (merck serono)20. Rebif (merck serono) Multiple SclerosisMultiple Sclerosis $ 1,668$ 1,668
  9. 9. BIOSIMILARSBIOSIMILARS BIOGENERICSBIOGENERICS FOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALS (FOB)(FOB)
  10. 10. BiosimilarsBiosimilars Biosimilars are the equivalent of generics forBiosimilars are the equivalent of generics for Biologicals.Biologicals. It is estimated that $20 billion worth of biologics willIt is estimated that $20 billion worth of biologics will come off patent by 2015come off patent by 2015 The global biosimilars market is expected to beThe global biosimilars market is expected to beThe global biosimilars market is expected to beThe global biosimilars market is expected to be worth US$19.4 billion by 2014, growing at a CAGRworth US$19.4 billion by 2014, growing at a CAGR of 89.1% from 2009 to 2014of 89.1% from 2009 to 2014 Biosimilars have potential to yield cost savings.Biosimilars have potential to yield cost savings. Sandoz Omnitrope the first Biosimilar to reachSandoz Omnitrope the first Biosimilar to reach patients.patients.
  11. 11. Difference between Small molecule Generics & BiosimilarsDifference between Small molecule Generics & Biosimilars
  12. 12. Market advantageMarket advantage Blockbuster Biotech InnovatorBlockbuster Biotech Innovator drugs to go off patent.drugs to go off patent. Biosimilars will cost 20Biosimilars will cost 20--25%25% lesser than that of parentlesser than that of parentlesser than that of parentlesser than that of parent biologics, which are amongstbiologics, which are amongst the most expensive medicines.the most expensive medicines. Annual consumer expenditureAnnual consumer expenditure for biologics has grown by 12for biologics has grown by 12–– 15%15%
  13. 13. 300 400 500 600 700 800 900 1 2 3 4 Global Markets for Biosimilars by type ($ US million) 0 100 200 300 2008 2009 4 1= Recombinant Non-glycosylated protein (Interferons, HGH, GCSF, Insulin, Interleukin) 2= Peptides (Glucagon, LH-RH, Calcitonin, Cyclosporine) 3= Recombinant glycosylated preotien (EPO, Mabs) Follitropin, Thyrotropin, DNase) 4= Others
  14. 14. Global Markets for Biosimilars by disease ($ US Million)Global Markets for Biosimilars by disease ($ US Million) 200 300 400 500 600 700 800 900 1 2 3 4 5 0 100 200 2008 2009 5 •1= Hematology •2= Chronic & Autoimmune disease •3= Growth related deficiencies •4= Oncology •5= Infectious & other diseases
  15. 15. Regulatory statusRegulatory status Owning to the complex natureOwning to the complex nature of Biologicals, strict testings areof Biologicals, strict testings are to be there.to be there. Pathway for approval in US isPathway for approval in US isPathway for approval in US isPathway for approval in US is still evolving.still evolving. Europe and Asia are theEurope and Asia are the forerunners in Biosimilars.forerunners in Biosimilars. India, China key players inIndia, China key players in upcoming Biosimilars market.upcoming Biosimilars market.
  16. 16. BIOSIMILARS : On the Brink of Accelerated Growth Prediction of biosimilar sales by product in seven major markets (France, Japan, Germany, Italy, Spain, UK and US) during 2008-2019. Sources-IMS, Datamonitor
  17. 17. Biosimilars in INDIABiosimilars in INDIA Dr. Reddy's and Biocon both brought biosimilar versionsDr. Reddy's and Biocon both brought biosimilar versions of Roche's (Basel) Rituximab to market.of Roche's (Basel) Rituximab to market. Zenotech LaboratoriesZenotech Laboratories-- developing at least six biosimilardeveloping at least six biosimilar versions of mAbs.versions of mAbs. Including Rituximab (which is ready to enter Phase III)Including Rituximab (which is ready to enter Phase III) and Herceptin (trastuzumab)and Herceptin (trastuzumab) Wockhardt have launched their EPO & Insulin.Wockhardt have launched their EPO & Insulin. Reliance life sciences has launched 3 biosimilarsReliance life sciences has launched 3 biosimilars Relipoeitin, Religrast & Reliferon in domestic market inRelipoeitin, Religrast & Reliferon in domestic market in 2008.2008.
  18. 18. Key Players in IndiaKey Players in India Dr. ReddysDr. Reddys BioconBiocon Intas BiopharmaceuticalsIntas Biopharmaceuticals Ranbaxy laboratoriesRanbaxy laboratoriesRanbaxy laboratoriesRanbaxy laboratories GlenmarkGlenmark Reliance Life sciencesReliance Life sciences BiologicalBiological--EE WockhardtWockhardt
  19. 19. Challenges for BiosimilarsChallenges for Biosimilars BiosimilarBiosimilar isis “similar”“similar” andand nono “generic”“generic” toto thethe firstfirst biologicsbiologics.. CompetitionCompetition-- samesame companiescompanies marketmarket thethe originaloriginal andand secondsecond--generationgeneration productsproducts andand therethere maymay notnot bebe aa markedmarked differencedifference inin priceprice..markedmarked differencedifference inin priceprice.. HigherHigher costcost ofof developmentdevelopment.. BiopharmaceuticalsBiopharmaceuticals areare lessless stablestable thanthan chemicalchemical basedbased pharmaceuticalspharmaceuticals andand thusthus requirerequire coldcold chainchain distributiondistribution andand havehave aa shortershorter shelfshelf lifelife.. BrandBrand developmentdevelopment andand highhigh promotionalpromotional activitiesactivities..
  20. 20. That’s all…That’s all… THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!THANK YOU!!!

×