Biosimilars Legislation Discussion

8/8/2019 Biosimilars Legislation Discussion

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Biosimilars 2007, George Washington University

Achieving A Middle Ground On

Balancing A Robust Scientific PathwayAnd Respect For IP Rights

(Promoting Continued BioPharma Innovation

While Advancing Access To Medicines)

JOHN M. ENGEL, ESQ.

MANAGING PARTNER

ENGEL & NOVITT, LLPTHE LAW FIRM THAT KNOWS ITS SCIENCE

1ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science

September 24, 2007

Washington, DC


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OUTLINEOUTLINE

Biopharmaceuticals Play A Crucial Role In An Era Of SignificantBiopharmaceuticals Play A Crucial Role In An Era Of SignificantScientific And R&D AdvancesScientific And R&D Advances

Barriers To Entry For Biosimilars Will Be Overcome As The IndustryBarriers To Entry For Biosimilars Will Be Overcome As The Industry

Evolves And As Science AdvancesEvolves And As Science Advances Biosimilars Represent A Myriad Of Opportunities For The BreadthBiosimilars Represent A Myriad Of Opportunities For The Breadth

Of The BioPharma IndustryOf The BioPharma Industry

Robust Biosimilars PathwayRobust Biosimilars Pathway Balancing Intellectual Property Rights (IPRs) To Enable InnovationBalancing Intellectual Property Rights (IPRs) To Enable Innovation

And Access To MedicinesAnd Access To Medicines Legislative Options And OpportunitiesLegislative Options And Opportunities A Robust BiosimilarsA Robust Biosimilars

Pathway With Data Exclusivity And Decoupling Of PatentsPathway With Data Exclusivity And Decoupling Of Patents ConclusionsConclusions A Middle Ground On Biosimilars Legislation IsA Middle Ground On Biosimilars Legislation Is

The material and viewpoints set forth in this slide deckand conveyed during this presentation are presented by the author


in his capacity as Managing Partner of Engel & Novitt, LLP.They do not represent and do not purport to represent the views of the law firm

or any current or former-client of the firm, and should not be construed as such.


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Scientific Advances Continue AffectingScientific Advances Continue Affecting

Regulatory/ Marketplace R&D OutputsRegulatory/ Marketplace R&D Outputs Medical science is entering an exciting era of discoveryMedical science is entering an exciting era of discovery

and research advances barely imaginable 20 years agoand research advances barely imaginable 20 years ago

Biomarkers, genomics, molecular targeting,Biomarkers, genomics, molecular targeting,nanotechnology, personalized medicine, proteomics,nanotechnology, personalized medicine, proteomics,

threshold of a revolution of advanced biologythreshold of a revolution of advanced biology

The inherent risks associated with innovating on thisThe inherent risks associated with innovating on thiscu ng e ge ecome even grea er as ec no ogycu ng e ge ecome even grea er as ec no ogycontinues advancing and regulatory paradigms strive tocontinues advancing and regulatory paradigms strive tocatch up while maintaining the Precautionary Principlecatch up while maintaining the Precautionary Principle

More biopharmaceuticals fail later in developmentMore biopharmaceuticals fail later in development

Biopharmaceuticals making it through the pipelineBiopharmaceuticals making it through the pipeline


--

patient populations and precise subpatient populations and precise sub--populationspopulations


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BiotechBiotech MedicinesMedicines R&DR&D PortfolioPortfolio IsIs

GrowingGrow ing ApprovalsApprovals NotNot KeepingKeeping PacePace

418450

369 371

324350

400

US DataUS Data

250But Only 4But Only 4

BiotechBiotechBLAsBLAs

81

143150

ApprovedApprovedBy FDA InBy FDA In

CY06CY06

50


1988 1993 1996 2000 2002 2004 2006

Reference: PhRMA Drugs In Development


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BiopharmaceuticalsBiopharmaceuticals KeyKey AssetsAssets InIn

IndustryIndustry PortfoliosPortfolios AsAs ScienceScience AdvancesAdvances Within this evolving R&D and regulatoryWithin this evolving R&D and regulatory

environment, biopharmaceuticals are a criticalenvironment, biopharmaceuticals are a critical

component of the entire industrys portfoliocomponent of the entire industrys portfolio This applies to both traditional innovator andThis applies to both traditional innovator and

A vibrant biopharmaceuticals business is necessaryA vibrant biopharmaceuticals business is necessary

for growth and developmentfor growth and development

Ability to target biopharmaceuticals R&D opens upAbility to target biopharmaceuticals R&D opens upa range of opportunities in the marketplacea range of opportunities in the marketplace

owerower--cos n erc angea e s once eg ma ecos n erc angea e s once eg ma eIP expiresIP expires

--


PremiumPremium--priced secondpriced second--generation biologicsgeneration biologics


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ExistingExisting ArtificialArtificial BarriersBarriers ToTo EntryEntry ForForBiosimilarsBiosimilars CanCan BeBe OvercomeOvercome

Biosimilars are an option for the entire breadth of theBiosimilars are an option for the entire breadth of theBioPharma industry, as more targetBioPharma industry, as more target--products andproducts andsponsors emerge as more pa en s exp responsors emerge as more pa en s exp re

BiosimilarsBiosimilars are the greatest opportunity to the mostare the greatest opportunity to the mostcapable and innovative companies across industrycapable and innovative companies across industry

InnovatorsInnovatorshave extensive biologics experiencehave extensive biologics experience

and will be able to produce biosimilars, and can beand will be able to produce biosimilars, and can be,,pipeline and attendant excess capacitypipeline and attendant excess capacity

Emerging biotech companiesEmerging biotech companies will use biosimilars aswill use biosimilars as

development of their own innovative pipelinedevelopment of their own innovative pipeline

Generics and CMOsGenerics and CMOs have capacity andhave capacity and


experience, some extensively in biologics, andexperience, some extensively in biologics, and

their investment timeframes are often shortertheir investment timeframes are often shorter


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BiosimilarsBiosimilars PresentPresent NovelNovel LCMLCM AndAndDevelopmentDevelopment OpportunitiesOpportunities

As the biosimilars debate moves forward in theAs the biosimilars debate moves forward in theU.S. and globally and political trades areU.S. and globally and political trades are

negotiated, wellnegotiated, well--positioned and forwardpositioned and forward--thinkingthinkingBioPharmas have a unique opportunityBioPharmas have a unique opportunity

Meeting the innovation challenge necessitatesMeeting the innovation challenge necessitates

leveraging opportunities in lead marketsleveraging opportunities in lead markets the U.S.the U.S. w r rw r r

The traditional U.S. RoW developmentThe traditional U.S. RoW development--marketin aradi m needs rethinkinmarketin aradi m needs rethinkin

Truly innovative companies will meet challengeTruly innovative companies will meet challenge


benefit in patientsbenefit in patients ---- capitalizing on biosimilarscapitalizing on biosimilars


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BiosimilarsBiosimilars RegulatoryRegulatory ConsiderationsConsiderations

RecognizingRecognizing && SeizingSeizing OpportunitiesOpportunities Biologics generally are considered complexBiologics generally are considered complex and yetand yet

FDA and other HAs continue approving innovatorFDA and other HAs continue approving innovator

biologics, which, by definition, are the ones we knowbiologics, which, by definition, are the ones we knowthe least about at the time of approvalthe least about at the time of approval

Bio ogics an rugs are presume to e i erent, utBio ogics an rugs are presume to e i erent, utonly the U.S. has distinct regulatory pathways, andonly the U.S. has distinct regulatory pathways, andthe EU is settin biosimilar recedents safel the EU is settin biosimilar recedents safel

Patient safety is critically important, but so is accessPatient safety is critically important, but so is accessto lifeto life--saving medicinessaving medicines and cost mattersand cost matters

Approvals of biosimilars are presumed to be a lossApprovals of biosimilars are presumed to be a lossfor innovator manufacturers, but a revisiting of thefor innovator manufacturers, but a revisiting of the


regu a ory s an ar s or o og cs cou eneregu a ory s an ar s or o og cs cou ene

innovatorsas well as patientsinnovatorsas well as patients


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PHSPHS ActAct LicensingLicensing CriteriaCriteria ForFor AA

BiologicBiologic[[42 U.S.C.42 U.S.C. 262(a)(2)(A)262(a)(2)(A)]] Broad De legat i on Of Au t ho r i t y B road De legat i on Of Au t ho r i t y

The Secretary shall approve a biologics licenseThe Secretary shall approve a biologics license----

(i)(i) on the basis of a demonstration thaton the basis of a demonstration that----(I)(I) the biological product that is the subject of thethe biological product that is the subject of the

application is safe, pure, and potent; andapplication is safe, pure, and potent; and

(II)(II) the facility in which the biological product isthe facility in which the biological product ismanufactured, processed, packed, or held meetsmanufactured, processed, packed, or held meetsstandards designed to assure that the biologicalstandards designed to assure that the biologicalproduct continues to be safe, pure, and potent;product continues to be safe, pure, and potent;andand

(ii)(ii) if the applicant (or other appropriate person)if the applicant (or other appropriate person)consents to the inspection of the facility that is theconsents to the inspection of the facility that is thesub ect of the a lication, in accordance withsub ect of the a lication, in accordance with


subsection (c) of this section.subsection (c) of this section.


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ImplicationsImplications OfOf ExistingExisting RegulatoryRegulatoryFrameworkFramework ForFor BiologicsBiologics ApprovalsApprovals

The burden is always on the sponsor toThe burden is always on the sponsor todemonstrate safet urit otenc under the PHSdemonstrate safet urit otenc under the PHS

Act (or safety and efficacy under the FD&C Act)Act (or safety and efficacy under the FD&C Act) -- --

always confidential, and always dependent uponalways confidential, and always dependent upon

what is being requested by the sponsor for its labelwhat is being requested by the sponsor for its label

FDA can apply the same criteria to biosimilarsFDA can apply the same criteria to biosimilars

,,approve PHS Act biologics as interchangeableapprove PHS Act biologics as interchangeable nothing more, nothing lessnothing more, nothing less



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ConsistentConsistent RegulatoryRegulatory StandardsStandards CanCan BeBe

TheThe TouchstoneTouchstone OfOf BiologicsBiologics RegulationRegulation For the patient, what matters is that all biotechFor the patient, what matters is that all biotech

products are made to consistent and appropriatelyproducts are made to consistent and appropriately

high regulatory standardshigh regulatory standards Standards must rely on data that supports theStandards must rely on data that supports the

statutory requirements o sa ety, purity, an potencystatutory requirements o sa ety, purity, an potency

Unless industry works with regulators, and otherUnless industry works with regulators, and other

,,increase for no net benefit in safety, or efficacyincrease for no net benefit in safety, or efficacy especially in a postespecially in a post--Vioxx worldVioxx world

It is unnecessarily risky for innovators own portfoliosIt is unnecessarily risky for innovators own portfoliosto overplay safety fears on FOBs, as innovator BLAsto overplay safety fears on FOBs, as innovator BLAs


are stumbling as a result of those argumentsare stumbling as a result of those arguments


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RegulatoryRegulatory OpportunitiesOpportunities ExistsExists ForForTheThe EntireEntire BioPharmaBioPharma IndustryIndustry

Approval of FOBs are presumed to be a loss forApproval of FOBs are presumed to be a loss forinnovators, and IP incentives a loss for FOBs sponsorsinnovators, and IP incentives a loss for FOBs sponsors

Revisiting regu atory criteria or io ogics anRevisiting regu atory criteria or io ogics anincentivizing research to generate more robustincentivizing research to generate more robustpipelines benefits entire BioPharma industry andpipelines benefits entire BioPharma industry andpatientspatients

Innovators can appropriately justify reduction inInnovators can appropriately justify reduction in

of biologics functionof biologics function

Biosimilars sponsors can legitimately asked toBiosimilars sponsors can legitimately asked to

prov e more ata t an requ re or tra t onaprov e more ata t an requ re or tra t onageneric drugsgeneric drugs


in the US rather than seeing R&D outsourced abroadin the US rather than seeing R&D outsourced abroad


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BiosimilarsBiosimilars AreAre AnAn OpportunityOpportunity AndAnd

CanCan FacilitateFacilitate RegulatoryRegulatory ProgressProgress Biosimilars enable reevaluation of biologics regulationsBiosimilars enable reevaluation of biologics regulations

and can enhance the future regulatory frameworkand can enhance the future regulatory framework

Better regulations will stimulate upgraded facilities andBetter regulations will stimulate upgraded facilities andmore efficient biologics manufacturing (PAT, QbD, etc.)more efficient biologics manufacturing (PAT, QbD, etc.)

Competitive marketCompetitive market--based pricing could enablebased pricing could enableconsumers to become more accepting of higher brandconsumers to become more accepting of higher brand

The perception of indefinite monopolies resultingThe perception of indefinite monopolies resultingfrom the continued absence of athwa s forfrom the continued absence of athwa s for

interchangeable biosimilars erodes that acceptanceinterchangeable biosimilars erodes that acceptance

The biosimilars debate allows policymakers toThe biosimilars debate allows policymakers to


restructure the regulatory framework within whichrestructure the regulatory framework within which

BioPharma operates and incentivize its future R&DBioPharma operates and incentivize its future R&D


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TheThe RegulatoryRegulatory EnvironmentEnvironment NeedsNeeds ToToEvolveEvolve JustJust AsAs TheThe ScienceScience IsIs EvolvingEvolving

The EU adopted legislative changes in the FML/NML toThe EU adopted legislative changes in the FML/NML toenable biosimilars and is continuing to approve themenable biosimilars and is continuing to approve them

as s own ncreas ng ex y app y ng ex s ngas s own ncreas ng ex y app y ng ex s ng

authority and only lacks authority for interchangeabilityauthority and only lacks authority for interchangeability Reimbursement is increasingly important andReimbursement is increasingly important and

formularies may drive patient options, and may makeformularies may drive patient options, and may makeFDA assessments of interchangeability less importantFDA assessments of interchangeability less important

Im ortant trades make FOBs less than zeroIm ortant trades make FOBs less than zero--sumsum

Regulatory burden can be reduced so BioPharmaRegulatory burden can be reduced so BioPharmaindustry gets updated regulations and old redundantindustry gets updated regulations and old redundant

Innovation can be stimulated and rewarded acrossInnovation can be stimulated and rewarded acrossthe full breadth of the BioPharma industrythe full breadth of the BioPharma industry


Legitimate IP for biologics and patient access can beLegitimate IP for biologics and patient access can be

mutually assuredmutually assured


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IPRsIPRs FuelFuel TheThe EngineEngine ThatThat AcceleratesAcceleratesTheThe BiomedicalBiomedical ResearchResearch EnterpriseEnterprise

IPRs are a critical factor in all innovation, especially withinIPRs are a critical factor in all innovation, especially withinthe BioPharma industry, ensuring the private sector has thethe BioPharma industry, ensuring the private sector has the

needed to develop new medicines vital to patient healthneeded to develop new medicines vital to patient health IPRs represent the legal protection for inventions, includingIPRs represent the legal protection for inventions, including

The protection afforded by IPRs allows inventors time toThe protection afforded by IPRs allows inventors time to

recoup their R&D investments, thereby providing investorsrecoup their R&D investments, thereby providing investorsthe assurance they need to risk the capital required to fundthe assurance they need to risk the capital required to fundboth the medical discovery process and new R&D initiativesboth the medical discovery process and new R&D initiatives

, ,, ,prosperity in inventions has been [elemental to] the advanceprosperity in inventions has been [elemental to] the advance

our country has made in the arts and sciences. Nothing moreour country has made in the arts and sciences. Nothing morestimulates effort than securit in the results of effort.stimulates effort than securit in the results of effort.


President Benjamin Harrison, Opening AddressPresident Benjamin Harrison, Opening Address

U.S. Patent System Centennial Celebration (1891)U.S. Patent System Centennial Celebration (1891)


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NexusNexus BetweenBetween ScientificScientific InnovationInnovationAndAnd IntellectualIntellectual PropertyProperty RightsRights (IPRs)(IPRs)

BasicBasic andand advancedadvanced scientificscientific researchresearch havehave beenbeenlon standinlon standin driversdrivers ofof innovationsinnovations beneficialbeneficial toto societsociet .. TheThepastpast half half centurycentury hashas witnessedwitnessed aa myriadmyriad of of scientificscientificdiscoveriesdiscoveries appliedapplied inin medicine,medicine, informationinformation technology,technology,biotechnolobiotechnolo a riculturala ricultural roductionroduction nanotechnolonanotechnolo andand aahosthost ofof otherother areasareas.. MoreMore recently,recently, thethe processesprocesses ofof creatingcreatingoror acquiringacquiring andand usingusing scientificscientific discoveriesdiscoveries andand innovationsinnovations

atat variousvarious stagesstages ofof developmentdevelopment havehave expandedexpanded withwith thethechangingchanging landscapelandscape ofof intellectualintellectual propertyproperty protectionsprotections inin thetheUnitedUnited StatesStates.. ScholarsScholars havehave pointedpointed outout thatthat bothboth thetheinputsinputs andand outputsoutputs ofof scientificscientific researchresearch increasinglyincreasingly areare

beingbeing protectedprotected throughthrough mechanismsmechanisms includingincludingbutbut notnotlimitedlimited totopatentingpatenting..


.. ,, .. ,, .. ,,ExperiencesExperiences inin thethe UnitedUnited StatesStates ScientificScientific CommunityCommunity:: AA ReportReport byby thethe ProjectProject OnOn ScienceScience AndAndIntellectualIntellectual PropertyProperty InIn TheThe PublicPublic InterestInterest (AAAS,(AAAS, 20072007)) (footnotes(footnotes omitted)omitted)..


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IPRsIPRs AreAre EssentialEssential ToTo TheThe BreadthBreadth OfOfTheThe BioPharmaBioPharma IndustryIndustry

As R&D and regulatory risks increase as the technologyAs R&D and regulatory risks increase as the technologyadvances, BioPharmas can become as risk adverse towardsadvances, BioPharmas can become as risk adverse towards

productsproducts IPRs are an essential safety net to protect the substantialIPRs are an essential safety net to protect the substantial

biopharmaceutical to market and to mitigate the high risk ofbiopharmaceutical to market and to mitigate the high risk offailure inherent in biopharmaceutical R&Dfailure inherent in biopharmaceutical R&D

R&D spend on unproven technologies that ultimately areR&D spend on unproven technologies that ultimately areexpected to have much more limited commercializationexpected to have much more limited commercializationo ortunitieso ortunities

When the macroWhen the macro--level risks associated with BioPharma R&Dlevel risks associated with BioPharma R&Dare exacerbated by a safety debate or other public healthare exacerbated by a safety debate or other public healthcrisis the BioPharma industr s develo ment of medicinescrisis the BioPharma industr s develo ment of medicines


becomes dependent upon respect for and enforcement ofbecomes dependent upon respect for and enforcement of

legitimate IPRslegitimate IPRs


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BalancingBalancing IPRsIPRs ToTo EnableEnable InnovationInnovation AndAndPatientPatient AccessAccess ToTo MedicinesMedicines

In return for IPRs (in particular, patent rights), an inventordiscloses to the world the patented research and the science

This patent-publication process makes important scientificinformation underlying a new medicine available

,and encouraging the continuation of scientific discovery

In return for disclosing the invention to the public -r v ng sc ence orwar - an nven or rece ves e r g o

exclude others from practicing the invention for a limitedtime

Once patents expire, pathways should exist to allowrobust competition to commence in the marketplace

That com etition and resultin market forces su l


demand) can regulate pricing and incentivize

continued innovation


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BalancingBalancing IPRsIPRs ToTo EnableEnable InnovationInnovation AndAndPatientPatient AccessAccess ToTo MedicinesMedicines

Denying or overriding IPRs for innovative medicines does notbenefit patients or enhance patient access to treatments

patients continuous access to innovative new medicines (oreven generic products) Nonetheless as a matter of cor orate res onsibilit theNonetheless as a matter of cor orate res onsibilit the

BioPharma industry must be responsive to serious concerns ofBioPharma industry must be responsive to serious concerns ofrapidlyrapidly--rising costs for public health systems for countries inrising costs for public health systems for countries in

the developed world, and the lack of affordability of lifethe developed world, and the lack of affordability of life--savingsavingmedications in developing countriesmedications in developing countries

Market trends are favoring competing products (includingMarket trends are favoring competing products (includinggenerics and biosimilars), which are one part of the solutiongenerics and biosimilars), which are one part of the solution

ener cs os m ars e p eep expen ures own y prov ngener cs os m ars e p eep expen ures own y prov ngaffordable medicines, enabling healthcare systems to remain viableaffordable medicines, enabling healthcare systems to remain viable Utilization of generics/biosimilars also can free up capital for moreUtilization of generics/biosimilars also can free up capital for more

innovative treatmentsinnovative treatments



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IPRsIPRs && PostPost--ExpiryExpiry CompetitionCompetition CombineCombineToTo FacilitateFacilitate InnovationInnovation AndAnd AccessAccess

New InnovativeMedicines

InnovationInnovation

offersoffersimprovedimproved

Generics/

High-QualityGenerics/Biosimilars

treatmenttreatmentoptionsoptions

renderingrendering

free up

funds for

Generic/Biosimilar

generics/generics/biosimilarsbiosimilars

obsoleteobsolete

medicines

Obsolescence

In a priceIn a price--sensitive environment, with aging a primary global demographic trend associated withsensitive environment, with aging a primary global demographic trend associated with


the need for more medicines,the need for more medicines, generics/biosimilars contribute to public health in a fundamental waygenerics/biosimilars contribute to public health in a fundamental way Use of generics/biosimilars when patents expireUse of generics/biosimilars when patents expire frees up health care $s for innovative therapiesfrees up health care $s for innovative therapies

Generics/Biosimilars trigger further innovation byGenerics/Biosimilars trigger further innovation by stimulating revitalization of legacy portfoliosstimulating revitalization of legacy portfolios


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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities AchievingAchieving BalanceBalance ForFor BiosimilarsBiosimilars

AA ViableViable Pathway Has Very Few Real RequirementsPathway Has Very Few Real Requirements DelegationDelegation of authority to FDA to licenseof authority to FDA to license

originally licensed under the PHS Actoriginally licensed under the PHS Act Authorities for FD&C Act FOBs already existAuthorities for FD&C Act FOBs already exist

r v v z ur v v z uinnovation in an increasinglyinnovation in an increasingly--risky R&D environmentrisky R&D environment

Continued decouplingContinued decoupling of the patent litigation and BLAof the patent litigation and BLArev ew process as ex s s o ay or o og csrev ew process as ex s s o ay or o og cs The case has not been made for linking patentThe case has not been made for linking patent

litigation to FDA review and approval of biologicslitigation to FDA review and approval of biologics

HatchHatch--Waxman is not really a viable model forWaxman is not really a viable model forbiosimilars beyond the core principle of balancebiosimilars beyond the core principle of balance

As it does toda decou lin ermits atentees toAs it does toda decou lin ermits atentees to


litigate to enforce patents whenever the patent lawslitigate to enforce patents whenever the patent laws

permit a case to be initiatedpermit a case to be initiated


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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities ScienceScience--BasedBased RegulatoryRegulatory StandardsStandards

FollowFollow--on versions of biologic drugs approvedon versions of biologic drugs approvedunder the FD&C Act need no new authorities:under the FD&C Act need no new authorities:

ComparabilityComparability already appliesalready applies Interchangeability is based on therapeuticInterchangeability is based on therapeutic

equivalenceequivalence (pharmaceutical equivalence plus(pharmaceutical equivalence plusbioequivalence)bioequivalence)

Biosimilar versions of biolo ics licensed under theBiosimilar versions of biolo ics licensed under thePHS Act need authority for interchangeabilityPHS Act need authority for interchangeabilitydetermination following licensure based ondetermination following licensure based on

-- Standard established isStandard established is safety, purity, potencysafety, purity, potency ComparabilityComparability already appliesalready applies


at the structural, functional, and clinical levelsat the structural, functional, and clinical levels


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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities RobustRobust PathwayPathway WithWith FDAFDA DeferenceDeference

Build on vast experience with biologicsBuild on vast experience with biologics statutorystatutoryenactments, regulatory implementation, andenactments, regulatory implementation, andadministrative precedents over the past 100 yearsadministrative precedents over the past 100 years and appropriately enable regulators and sponsorsand appropriately enable regulators and sponsors

Enable scientific experts at FDA to applyEnable scientific experts at FDA to apply consistentconsistent

andand predictablepredictable standards to all biologics to:standards to all biologics to: Encourage competitionEncourage competition

Stimulate innovationStimulate innovation through better use of priorthrough better use of prior

Build in opportunities/incentives forBuild in opportunities/incentives for secondsecond--eneration biolo icseneration biolo ics


Facilitate globalFacilitate global harmonizationharmonization


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Legislative Options & OpportunitiesLegislative Options & Opportunities Granting Exclusivity & Respecting IPRsGranting Exclusivity & Respecting IPRs

Various forms ofVarious forms ofexclusivityexclusivity have been proposed, withhave been proposed, withthe EU model still meriting considerationthe EU model still meriting consideration

double that of the fourdouble that of the four--year period in the U.S. underyear period in the U.S. underthe NCE exclusivity provisions, and a preclusion onthe NCE exclusivity provisions, and a preclusion on. .. . --

NCE periodNCE period

Effectively combines data and market exclusivityEffectively combines data and market exclusivity ncen v zes con nue w po en a or +ncen v zes con nue w po en a or +

exclusivity period for significant new usesexclusivity period for significant new uses All types ofAll types ofpatentspatents should be appropriately respectedshould be appropriately respected

and enforced in every jurisdiction in which they applyand enforced in every jurisdiction in which they apply When patents expire, competition must be seen toWhen patents expire, competition must be seen to

beginbegin


In all cases,In all cases, trade secretstrade secrets must continue to bemust continue to be

respected by and for all sponsorsrespected by and for all sponsors


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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities DecouplingDecoupling PatentsPatents AndAnd BLABLA LicensureLicensure

The biotechnology industry has grown andThe biotechnology industry has grown andprospered without any link between patents,prospered without any link between patents,patent litigation, and FDA licensure of productspatent litigation, and FDA licensure of products

Decoupling enables FDA to utilize its scientificDecoupling enables FDA to utilize its scientificexpertise and resources where it is mostexpertise and resources where it is mostappropriateappropriate on its public health mission ofon its public health mission of

Courts can continue to enforce biotech patentsCourts can continue to enforce biotech patents

-- -- Like cases before it,Like cases before it, Amgen v RocheAmgen v Roche pegylatedpegylated


Court demonstrates viability of decouplingCourt demonstrates viability of decoupling


26/31

NewNew Biosimilars Biosimilars PathwaysPathways AddressingAddressing EvergreeningEvergreening ClaimsClaims

Waxman, Schumer,Clinton included all

these pathways

ars)12

Full BLA URDE

N

VI

TY(

ye

subsection (a)

No regulatory

relief

SecondGeneration ?

e. .

H.E.L.P Legislationincludes these two

pathways AT

ORY

EXCLUSI

extrapolationbetweenindications

No reference toa rior roduct Interchangeable1

pegylation

REGUL

Biosimilar

Biosimilar


Standards are Safety, Purity and Potency


27/31

ExclusivityExclusivity && PathwayPathway DataData StandardsStandardsForFor SecondSecond--GenerationGeneration BiologicsBiologics

Pathways require the samedata as all are NMEs

(year

s)

12

Full BLASecond

Generation ? URDE

N

URDE

N

S

IVITY

subsection (a)

No regulatory

relief

e.g.pegylation

Full datarequirements AT

ORY

AT

ORY

H.E.L.P Legislationonly includes these

two pathways

EXCL



Noextrapolationbetweenindications

No reference to

REGUL

REGUL

BiosimilarBiosimilar

a prior product



28/31

ExclusivityExclusivity && FlexibleFlexible DataData StandardsStandardsForFor SecondSecond--GenerationGeneration BiologicsBiologics

FOR SAME MOAIntermediate datarequirements?

(year

s)

12

Full BLA

ny ex rapo a on

between indications?Any reference to aprior product?

URDE

N

S

IVITY

subsection (a)

No regulatory

relief AT

ORY

EXCL



SecondGeneration ?

e.g. REGUL

Biosimilar

Biosimilar



29/31

ExclusivityExclusivity AndAnd SecondSecond--GenerationGenerationBiologicsBiologics PathwayPathway OpportunitiesOpportunities

Can legislation include

ears)12

Full BLA

a ese ca egor es,based on MOA?

URDE

N

IV

ITY( subsection (a)

No regulatory

relief AT

ORY

EXCLU



SecondGeneration ?

e.g. REGUL

Biosimilar

Biosimilar


C l iC l i AA MiddlMiddl G dG d OO


30/31

ConclusionsConclusions AA MiddleMiddle GroundGround OnOnBiosimilarsBiosimilars LegislationLegislation IsIs AchievableAchievable

A constructive solution for the BioPharma industry, regulators,A constructive solution for the BioPharma industry, regulators,health care providers, and patients is readily achievablehealth care providers, and patients is readily achievable

Res ect for le itimate IPRs and ensuin marketRes ect for le itimate IPRs and ensuin market--basedbasedcompetition following patent expiry are both achievablecompetition following patent expiry are both achievable

An appropriate balance can drive continued innovation andAn appropriate balance can drive continued innovation andenable patient access to innovative and affordable medicinesenable patient access to innovative and affordable medicines

Competition from highCompetition from high--quality biosimilars should be encouragedquality biosimilars should be encouraged Neither side should fear a competitive marketplaceNeither side should fear a competitive marketplace

The global biotechnologyThe global biotechnology--based industry can afford tobased industry can afford torecogn ze s own success an e p es gn s u urerecogn ze s own success an e p es gn s u ure

Support consistent regulatory standards for all biologicsSupport consistent regulatory standards for all biologics Seize opportunity to use stateSeize opportunity to use state--ofof--the art technology tothe art technology to

Embrace global health authorities adoption ofEmbrace global health authorities adoption ofcomparability principles to limit trials and sizecomparability principles to limit trials and size


evolving regulatory paradigms especially in RoWevolving regulatory paradigms especially in RoW

Develop improved and superior biologicsDevelop improved and superior biologics


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Thank You!

John M. Engel, Esq.Mana in Partner

ENGEL & NOVITT, LLPTHE LAW FIRM THAT KNOWS ITS SCIENCE

. .

202.207.3303

[email protected]

The material and viewpoints set forth in this slide deckand conveyed during this presentation are presented by the author

in his capacity as Managing Partner of Engel & Novitt, LLP.


They do not represent and do not purport to represent the views of the law firmor any current or former-client of the firm, and should not be construed as such.

Biosimilars Legislation Discussion

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Transcript of Biosimilars Legislation Discussion