EMSOP Chronicles Vol.16 Issue 2 Part 2 (Spring 2025)

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EMSOP EMSOP

CHRONICLES

PhotoCredit:https://www.istockphoto.com/photo/different-skincare-product-set-fcial-cleanser-toner-essence-serum-cream-on-whitegm2023847862-561592156?searchscope=image%2Cfilm

Socialmediahasheightenedtheexposure offacialcleanserstoconsumersworldwide,withavarietyofcleansersforeach individualskincareneeds.However,the diversityofcleansersliesinthedifferent ingredientsandformulationstailoredto one’sskincareneeds.Thesciencebehind facialcleanserswillhelpnarrowdown one’sdecisionwhenchoosingthemost appropriateproduct.Let’sbreakdown somescientificconceptswhenobserving

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thatawell-executedlegalplancanbeas profitableasthescienceitself.

Thisapproachisalreadybecomingablueprintforotherbiologics.Drugslike Keytruda(pembrolizumab)andEnbrel (etanercept)aresurroundedbysimilarly expansiveportfoliosofsecondarypatents.8 Asbiosimilardevelopersapproachtheend oftheirexclusivityperiods,they’rewith dozensofoverlappingprotections,each requiringtime,money,andlegalresources todispute.

Whilethejustificationisoftenframedas protectinginnovation,thedownstreameffectisclear:slowercompetition,higher prices,andreducedaccessforpatients.It’s abusinessmodelbuiltnotjustonscientific discovery,butonlegaldurability,anability tooutlastchallengersthroughsheervolumeofprotection.

Bydelayingbiosimilarentrythroughthe thicketstrategy,AbbVieisestimatedto

howfacialcleanserswork.

Cleansersaremadeupofsurfactants,moleculesthatcaninteractwithbothpolarand nonpolarmolecules.Thesurfactantsinfacialcleanserscaninteractwithwater,a polarmolecule,andoilordirt,nonpolar molecules.1 Cleanserscanalsobefurther classifiedbasedonthechargesofthemoleculesthatmakeupthecleanser.Theskin typicallyhasanacidicorlowpH,so cleanserswithdifferentlychargedmole-

havecosttheU.S.healthcaresystemover $19billioninexcessspending.9 While biosimilarshavefinallyenteredthemarket, thepricingimpacthasbeenlessdramatic thanmanyhoped.Unlikesmall-molecule generics,whichcanreducepricesby80–90%,biosimilardiscountshavesofarbeen modest,allthanksinparttoformularycontracts,rebatetraps,andresidualbrandloyalty.10,11

Forpatients,thishasmeantyearsofhigh out-of-pocketcostsandlimitedaccesstoa criticaltherapy,whichareallcoststhat cannotberecoupedwithanewentering biosimilar.

Monoclonalantibodiesrepresentsomeof themostpromisingadvancesinmodern therapeutics.Butifaccessischokedoffby legaldesign,theirpotentialbecomesrestrictedtoprivilegeratherthanapublic good.ThecaseofHumirashowswhathappenswhenintellectualpropertylawisused

culeswillhaveadistinctinteractionwith theskin.IfacleanserhaschargedmoleculesthatincreasethepHoftheformulation,thenthecleansermayincreasepenetrationofthecleansertowashtheskinof dirtandoilwhilesimultaneouslyhydrating theskin.Aftercleaning,theskinfeels tighteranddrierbecausethesoapcauses theproteinsintheskintobetemporarily unabletoholdwater.2 Thisphenomenon explainswhymoisturizingaftercleansing isimportantinskincare.Findingthebalancebetweencleansingandprotectingthe skinbarrierisessentialwhencreatingand choosingfacialcleansers.

Mostimportantly,facialcleansershouldbe entirelyrinsedfromtheskintoprevent furtherskinconditionsfromoccurring. Skinconditions,suchaseczemaandacne, requireothertopicalformulationsalongsidefacialcleansers,soitisimportantto askyourdoctorordermatologistwhatthe bestchoiceis.1 Choosingafacialcleanser appropriateforyourskinisessentialto maintaininggoodhygiene.

References

1.Mukhopadhyay,Partha.“CleansersandTheirRoleinVariousDermatologicalDisorders.”IndianJournalofDermatology,vol.56,no.1,2011,p.2, www.ncbi.nlm.nih.gov/pmc/articles/PMC3088928/#ref1,https://doi.org/ 10.4103/0019-5154.77542.

2.Draelos,ZoeDiana.“TheSciencebehindSkinCare:Cleansers.”Journal ofCosmeticDermatology,vol.17,no.1,12Dec.2017,pp.8–14,https://doi. org/10.1111/jocd.12469.

notjusttoprotectinnovation,buttoown themarket.

References

1.EconomicAnalysisofAvailabilityofFollow-onProteinProducts.ASPE. PublishedJuly27,2009.AccessedApril20,2025.https://aspe.hhs.gov/reports/economic-analysis-availability-follow-protein-products-0

2.EllisCR,AzmatCE.Adalimumab.PubMed.Published2023.https://www. ncbi.nlm.nih.gov/books/NBK557889/

3.BrittainB,BrittainB.AbbViewinsappealinantitrustcaseoverHumira “patentthicket.”Reuters.https://www.reuters.com/legal/litigation/abbviewins-appeal-antitrust-case-over-humira-patent-thicket-2022-08-02/.PublishedAugust2,2022.

4.GardnerJ.Twodecadesand$200billion:AbbVie’sHumiramonopoly nearsitsend.BioPharmaDive.PublishedMarch17,2022.https://www.biopharmadive.com/news/humira-abbvie-biosimilar-competition-monopoly/ 620516/

5.ShaverA.Washington,DC.BiosimilarsLawBulletin.PublishedJanuary 14,2025.AccessedApril20,2025.https://www.biosimilarsip.com/ 2025/01/14/how-the-u-s-compares-to-europe-on-biosimilar-approvals-andproducts-in-the-pipeline-updated-january-13-2025/

6.DrugPricingInvestigation.https://docs.house.gov/meetings/GO/ GO00/20210518/112631/HHRG-117-GO00-20210518-SD007.pdf

7.GhoshI,GutkaHJ,KrauseML,ClemensR,KashiRS.Asystematicreviewofcommercialhighconcentrationantibodydrugproductsapprovedin theUS:formulationcomposition,dosageformdesignandprimarypackaging considerations.mAbs.2023;15(1).doi:https://doi.org/ 10.1080/19420862.2023.2205540

8.Overpatented.Keytruda’sPatentWall.https://www.i-mak.org/wp-content/ uploads/2021/05/i-mak.keytruda.report-2021-05-06F.pdf

9.DrugPricingInvestigation.https://docs.house.gov/meetings/GO/ GO00/20210518/112631/HHRG-117-GO00-20210518-SD007.pdf

10.IndujaRatakonda.ImpactofDrugPatentExpiryonPrices:Recent Trends.Artixio.PublishedOctober19,2024.https://www.artixio.com/post/ impact-of-drug-patent-expiry-on-prices-recent-trends 11.FengK,RussoM,MainiL,KesselheimAS,RomeBN.PatientOut-ofPocketCostsforBiologicDrugsAfterBiosimilarCompetition.JAMAhealth forum.2024;5(3):e235429-e235429.doi:https://doi.org/10.1001/jamahealthforum.2023.5429

Thankyoutoallthecontributorsinthispublicationof EMSOPChronicles!

Editor-in-Chief: AshleyHuang

AssociateEditor: AnishaDesai

LayoutDirector: RadiyaRahman

LayoutDirector-Elect: AmritaTejwani

Secretary: MariaGhaly

HumansofEMSOPDirectors: RiyaMankadandRiyaPatel

ArtisticDirectors: JustinVatanapraditandSamJacob

PublicRelations: CarlaArca-SeddaandJoannaKusmierski

PGCRepresentative: SakshiShah

StaffWriters: AmritaTejwani,AnishaDesai, AshleyHuang,CarlaArca-Sedda,JoannaKusierski, JustinVatanapradit,MariaGhaly,RadiyaRahman,RiyaMankad,RiyaPatel,SakshiShah,SamJacob,Vinayak Shende

StaffEditors: AmritaTejwani,AnishaDesai, AshleyHuang,CarlaArca-Sedda,JoannaKusierski, JustinVatanapradit,MariaGhaly,RadiyaRahman,RiyaMankad,RiyaPatel,SakshiShah,SamJacob

HumansofEMSOPStaff: RiyaMankadandRiyaPatel

Disclaimer: TheopinionsexpressedinEMSOPCHRONICLESdonotreflecttheviewsofthe PharmacyGoverningCouncil(PGC)orErnestMarioSchoolofPharmacy(EMSOP).

Forquestions,comments,andinformationonhowtogetinvolved,e-mail emsopchronicles@gmail.com.

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