Basic Information of Biosimilars. This ppt is basd on secondary data by various internet sites. For downloading, send me an e-mail.

1. BiosimilarsBiosimilars
… the Growth Opportunities… the Growth Opportunities
By-
Swati Varma
MBA-BT
IMED

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. 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. 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. 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.

7. 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

8. 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

9. 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

12. BIOSIMILARSBIOSIMILARS
BIOGENERICSBIOGENERICS
FOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALSFOLLOW ON BIOLOGICALS
(FOB)(FOB)

13. 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.

14. Difference between Small molecule Generics & BiosimilarsDifference between Small molecule Generics & Biosimilars

15. 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%

16. 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

17. 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

18. 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.

20. 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

21. 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.

23. 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

24. 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..

25. 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!!!