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`EXHIBIT 81
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`PageID #: 37826
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`FDA’s Overview of the Regulatory Guidance for
`the Development and Approval of Biosimilar
`
`Products in the US
`
`Leah Christl, Ph.D.
`Associate Director for Therapeutic Biologics
`OND Therapeutic Biologics and Biosimilars Team/CDER/FDA
`
`

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`PageID #: 37827
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`Overview of Presentation
` Overview
`– Background
`– Definitions
`– Approval Pathway for Biosimilars – General
`Requirements
`
`
` Development of Biosimilars
`– FDA Guidance Documents
`– Approach to Development
`– Specific Development Concepts
`
`2
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`PageID #: 37828
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`Overview
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`

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`PageID #: 37829
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`Background
` The Biologics Price Competition and Innovation
`Act of 2009 (BPCI Act) was passed as part of
`health reform (Affordable Care Act) that
`President Obama signed into law on March 23,
`2010.
`
` BPCI Act creates an abbreviated licensure
`pathway for biological products shown to be
`biosimilar to or interchangeable with an FDA-
`licensed reference product.
`
`
`4
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`What is an Abbreviated Licensure
`Pathway for Biological Products?
` A biological product that is demonstrated to be “highly similar”
`to an FDA-licensed biological product (the reference product)
`may rely for licensure on, among other things, publicly-available
`information regarding FDA’s previous determination that the
`reference product is safe, pure and potent.
`
` This licensure pathway permits a biosimilar biological product to
`be licensed under 351(k) of the Public Health Service Act (PHS
`Act) based on less than a full complement of product-specific
`preclinical and clinical data  abbreviated licensure pathway.
`
`5
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`PageID #: 37831
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`Definition: Biosimilarity
`
`Biosimilar or Biosimilarity means:
`
`
` that the biological product is highly similar to the
`reference product notwithstanding minor
`differences in clinically inactive components; and
`
` there are no clinically meaningful differences
`between the biological product and the reference
`product in terms of the safety, purity, and potency
`of the product.
`
`6
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`PageID #: 37832
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`Definition: Reference Product
`
`Reference Product means:
` the single biological product, licensed under
`section 351(a) of the PHS Act, against which a
`biological product is evaluated in an application
`submitted under section 351(k) of the PHS Act.
`
`
`Note: A biological product, in a 351(k) application, may
`not be evaluated against more than 1 reference
`product.
`
`7
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`PageID #: 37833
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`Definition: Interchangeability
`Interchangeable or Interchangeability means:
` the biological product is biosimilar to the reference product;
` it can be expected to produce the same clinical result as the
`reference product in any given patient; and
` for a product that is administered more than once to an individual,
`the risk in terms of safety or diminished efficacy of alternating or
`switching between use of the product and its reference product is
`not greater than the risk of using the reference product without
`such alternation or switch.
`
`
`Note: The interchangeable product may be substituted for the reference
`product without the intervention of the health care provider who
`prescribed the reference product.
`
`8
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`PageID #: 37834
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`General Requirements
`
`A 351(k) application must include information demonstrating
`that the biological product:
` Is biosimilar to a reference product;
` Utilizes the same mechanism(s) of action for the proposed
`condition(s) of use -- but only to the extent the mechanism(s) are
`known for the reference product;
` Condition(s) of use proposed in labeling have been previously
`approved for the reference product;
` Has the same route of administration, dosage form, and strength
`as the reference product; and
` Is manufactured, processed, packed, or held in a facility that meets
`standards designed to assure that the biological product continues
`to be safe, pure, and potent.
`
`9
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`General Requirements: 351(k) Application
`The PHS Act requires that a 351(k) application include, among other
`things, information demonstrating biosimilarity based upon data
`derived from:
` Analytical studies demonstrating that the biological product is
`“highly similar” to the reference product notwithstanding minor
`differences in clinically inactive components;
` Animal studies (including the assessment of toxicity); and
` A clinical study or studies (including the assessment of
`immunogenicity and pharmacokinetics (PK) or pharmacodynamics
`(PD)) that are sufficient to demonstrate safety, purity, and potency
`in 1 or more appropriate conditions of use for which the reference
`product is licensed and for which licensure is sought for the
`biosimilar product.
`FDA may determine, in its discretion, that an element described above is unnecessary in
`a 351(k) application.
`
`10
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`PageID #: 37836
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`Standard for Licensure
` FDA shall license the biological product under section 351(k)
`of the PHS Act if—
`– FDA determines that the information submitted in the
`application (or supplement) is sufficient to show that the
`biological product—
`• (i) is biosimilar to the reference product; or
`• (ii) meets the standards described in 351(k)(4), and therefore is
`interchangeable with the reference product; and
`– Applicant (or other appropriate person) consents to
`inspection of the facility, in accordance with section 351(c).
`
` Note: BPCI Act does not require that FDA promulgate guidance or
`regulation before reviewing or approving a 351(k) application.
`
`•11
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`PageID #: 37837
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`Non-US-Licensed
`Comparator Products
` The PHS Act defines the “reference product” for a 351(k)
`application as the “single biological product licensed
`under section 351(a) against which a biological product is
`evaluated.”
` Data from animal studies and certain clinical studies
`comparing a proposed biosimilar product with a non-US-
`licensed product may be used to support a
`demonstration of biosimilarity to a US-licensed reference
`product.
` Sponsor should provide adequate data or information to
`scientifically justify the relevance of these comparative
`data to an assessment of biosimilarity and to establish an
`acceptable bridge to the U.S.-licensed reference product.
`
`12
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`PageID #: 37838
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`Support for Use of
`Non-US-Licensed Comparator
` Type of bridging data needed would include:
`– Direct physico-chemical comparison of all 3 products
`(proposed biosimilar to US-licensed reference product;
`proposed biosimilar to non-US-licensed comparator
`product; US-licensed reference product to non-US-licensed
`comparator product)
`– Likely 3-way bridging clinical PK and/or PD study
`
` All three pair-wise comparisons should meet the pre-
`specified acceptance criteria for analytical and PK and/or
`PD similarity.
`
`13
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`

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`PageID #: 37839
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`Overview of FDA’s Approach
`to the Development of
`Biosimilars -
`Specific Development
`Concepts
`
`

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`PageID #: 37840
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`FDA Biosimilars Draft Guidances
`
`1. Scientific Considerations in Demonstrating Biosimilarity to a
`Reference Product (2012)
`2. Quality Considerations in Demonstrating Biosimilarity to a
`Reference Protein Product (2012)
`3. Biosimilars: Questions and Answers Regarding
`Implementation of the Biologics Price Competition and
`Innovation Act of 2009 (2012)
`4. Formal Meetings Between the FDA and Biosimilar Biological
`Product Sponsors or Applicants (2013)
`5. Clinical Pharmacology Data to Support a Demonstration of
`Biosimilarity to a Reference Product (2014)
`
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm
`
`15
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`PageID #: 37841
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`FDA Guidance
` Focus on therapeutic protein products
` Discusses general scientific principles
` Outlines a stepwise approach to
`generating data and the evaluation of
`residual uncertainty at each step
` Introduces the totality-of-the-evidence
`approach
`
`16
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`

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`PageID #: 37842
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`Key Development Concepts
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`

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`PageID #: 37843
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`Goals of “Stand-alone” and
`Biosimilar Development are Different
` The goal is to demonstrate
` The goal of “stand-alone”
`biosimilarity between the
`development is to
`proposed product and a
`demonstrate that the
`reference product
`proposed product is safe and
`efficacious
`
`
`
` The goal is not to
`independently establish
`safety and effectiveness of
`the proposed product
`
` Drug development starts with
`preclinical research, moves to
`Phase 1, 2 and culminates in
`Phase 3 “pivotal” trials to
`show safety and efficacy
`
`What does this difference mean from a development perspective?
`
`18
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`PageID #: 37844
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`Stepwise Evidence Development
` FDA has outlined a
` Apply a step-wise approach to
`stepwise approach to
`data generation and the
`generate data in support
`evaluation of residual
`of a demonstration of
`uncertainty
`biosimilarity
` When considering designing a
`study, evaluate and
`understand the question being
`answered
`– What is the residual uncertainty?
`– What differences have been
`observed and how best to
`evaluate the potential impact?
`– What will the data tell you? Will
`it answer the question?
`
`– Evaluation of residual
`uncertainty at each step
`
` Totality-of-the-evidence
`approach in evaluating
`biosimilarity
`
`– There is no one “pivotal”
`study that demonstrates
`biosimilarity
`
`
`
`19 19
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`PageID #: 37845
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`Totality of the Evidence
` No “one size fits all” assessment
`
` FDA scientists will evaluate the
`applicant’s integration of various types
`of information to provide an overall
`assessment that a biological product is
`biosimilar to a US-licensed reference
`product.
`
`
`20
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`

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`PageID #: 37846
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`Analytical Similarity Data -
`The Foundation of a Biosimilar Development Program
`
` Extensive structural and functional characterization
`is necessary
` Understand the molecule and function
` Identify critical quality attributes and clinically active
`components
` Understanding the relationship between quality
`attributes and the clinical safety & efficacy profile
`aids ability to determine residual uncertainty about
`biosimilarity and to predict expected “clinical
`similarity” from the quality data.
`
`
`
`21
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`PageID #: 37847
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`Generating Analytical Similarity Data
`
` Characterize reference product variability and product
`
`quality characteristics
` Characterize proposed biosimilar product quality
`characteristics
` Identify and evaluate impact of differences
`– The potential effect of the differences on safety,
`purity, and potency should be addressed and
`supported by appropriate data
`– Must be highly similar and no clinically meaningful
`differences
`
`
`
`
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`22
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`PageID #: 37848
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`
`
`Assessing Analytical Similarity
`Important factors for consideration in assessing analytical
`similarity, including:
`– Expression System
`– Manufacturing Process
`– Assessment of Physicochemical Properties
`– Functional Activities
`– Receptor Binding and Immunochemical Properties
`– Impurities
`– Reference Product and Reference Standards
`– Finished Drug Product
`– Stability
`
`23 23
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`PageID #: 37849
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`Choice of Analytics
`
` It is expected that appropriate analytical test methods
`will be selected based on:
`– the nature of the protein being characterized,
`– knowledge regarding the structure, and
`– heterogeneity of the reference product and proposed
`biosimilar product including
`• known and potential impurities, and
`• characteristics that are critical to product performance
`
`24
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`PageID #: 37850
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`Animal Data
` Animal toxicity data are useful when uncertainties
`remain about the safety of the proposed product prior
`to initiating clinical studies.
`
` The scope and extent of animal toxicity studies will
`depend on publicly available information and/or data
`submitted in the biosimilar application regarding the
`reference product and the proposed biosimilar
`product, and the extent of known similarities or
`differences between the two.
`
` A comparison of PK/PD in an animal model may be
`useful.
`
`25
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`

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`PageID #: 37851
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`Clinical Studies
`
` The nature and scope of clinical studies will
`depend on the extent of residual uncertainty
`about the biosimilarity of the two products
`after conducting extensive structural and
`functional characterization and, where
`relevant, animal studies.
`
`26
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`PageID #: 37852
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`Type of Clinical Data
`
` As a scientific matter, FDA expects an adequate clinical PK,
`and PD if relevant, comparison between the proposed
`biosimilar product and the reference product.
`
` As a scientific matter, at least 1 clinical study that includes a
`comparison of the immunogenicity of the proposed and
`reference product generally will be expected.
`
` As a scientific matter, a comparative clinical study will be
`necessary to support a demonstration of biosimilarity if
`there are residual uncertainties about whether there are
`clinically meaningful differences between the proposed and
`reference products based on structural and functional
`characterization, animal testing, human PK and PD data,
`and clinical immunogenicity assessment.
`
`27
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`

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`PageID #: 37853
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`Comparative Human PK and PD Data
` Comparative human PK (and PD) data :
`Demonstrate PK (and PD) similarity
`–
`Assess clinically meaningful differences between the
`–
`proposed biosimilar and the reference product
` PK and/or PD is generally considered the most
`sensitive clinical study/assay in which to assess for
`differences, should they exist
` Support a demonstration of biosimilarity with the
`assumption that similar exposure (and
`pharmacodynamic response) provides similar efficacy
`and safety (i.e., an exposure-response relationship
`exists)
` Clinical PK data generally will be expected; PD data
`desirable (case by case consideration)
`
`28
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`

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`PageID #: 37854
`
`
`Human PK and PD Study
`Considerations
`  Study Design
`– Study population: an adequately sensitive population to detect any
`differences, should they exist
`– PD endpoint: Reflect the biological effect(s) of the drug, they may (or
`may not) be on mechanistic path of MOA or disease process
`– Route of administration: all routes vs. a single route
` Data analysis plan
`– Acceptance range: 80-125% (90% CI for PK and PD), scientifically
`justify use of other ranges
`– Choice of primary endpoints (e.g., PK—AUC, Cmax; PD—AUEC)
` Others
`– Incidence of immunogenicity
`
`29
`
`

`

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`PageID #: 37855
`
`Comparative Clinical Study
`Considerations
` A comparative clinical study for a biosimilar
`development program should be designed to
`investigate whether there are clinically meaningful
`differences between the proposed product and the
`reference product.
` Consider the adequacy of population, sample size and
`study duration to detect differences, should they exist.
` The goal of the study is to support a demonstration of
`no clinically meaningful differences.
`– Typically, an equivalence design with symmetric inferiority
`and superiority margins would be used, but other designs
`may be justified depending on product-specific and program-
`specific considerations.
`
`30
`
`

`

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`PageID #: 37856
`
`Highly Similar Analytical and PK/PD Data
`s e
`Assumes Lower Risk of Clinical Differenc
`
`Additional
`Clinical
`Studies
`Clin Pharm
`Nonclinical
`Analytical
`
`Totality of the evidence to demonstrate biosimilarity
`
`31
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 563-10 Filed 11/09/20 Page 57 of 142
`PageID #: 37857
`
`Extrapolation
` The potential exists for a biosimilar product to be
`approved for one or more conditions of use for
`which the US-licensed reference product is licensed
`based on extrapolation of data intended to
`demonstrate biosimilarity in one condition of use.
`
`
` Sufficient scientific justification for extrapolating
`data is necessary.
`
`
`32
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`

`

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`PageID #: 37858
`
`Extrapolation Considerations
` FDA guidance outlines factors/issues that should be
`considered when providing scientific justification for
`extrapolation including, for example*,
`– The MOA(s) in each condition of use for which licensure is
`sought
`– The PK and bio-distribution of the product in different patient
`populations
`– The immunogenicity of the product in different patient
`populations
`– Differences in expected toxicities in each condition of use and
`patient population
` Differences between conditions of use do not necessarily
`preclude extrapolation
`
`*This list is a subset of the issues outlined in the FDA guidance document
`
`33
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`

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`PageID #: 37859
`
`Summary of Key Concepts
` Demonstrating biosimilarity is different from “stand-
`alone” product development
`– A “stand-alone”-like program will not demonstrate
`biosimilarity
`– The approach and the development program should and will be
`different based on the intended outcome to demonstrate
`biosimilarity
` Analytical similarity data is the foundation of biosimilar
`development
`– Understanding the relationship between quality attributes and
`the clinical safety & efficacy profile aids ability to determine
`residual uncertainty about biosimilarity and to predict
`expected “clinical similarity” from the quality data.
`
`
`
`
`34
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`

`

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`PageID #: 37860
`
`Summary of Key Concepts
` The nature and scope of clinical studies will depend on the
`extent of residual uncertainty about the biosimilarity of the two
`products after conducting an extensive analytical similarity
`assessment.
` Comparative clinical study(ies) will be necessary to support a
`demonstration of biosimilarity if there are residual
`uncertainties about whether there are clinically meaningful
`differences between the proposed biosimilar and reference
`product
` Scientific justification must be provided to support extrapolation
`to other conditions of use
` The content of a biosimilar development program is based on
`stepwise development and approvability is based on the totality
`of the evidence submitted by the sponsor
`
`
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`Case 1:18-cv-00924-CFC-SRF Document 563-10 Filed 11/09/20 Page 61 of 142
`PageID #: 37861
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`Thank you for your attention.
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`Case 1:18-cv-00924-CFC-SRF Document 563-10 Filed 11/09/20 Page 62 of 142
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`EXHIBIT 82
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`Case 1:18-cv-00924-CFC-SRF Document 563-10 Filed 11/09/20 Page 63 of 142
`PageID #: 37863
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`Biosimilars: Considerations for Payers
`
`James Smeeding, RPh, MBA; Daniel C. Malone, RPh, PhD; Monica Ramchandani, PhD;
`Bradley Stolshek, PharmD; Larry Green, PharmD; and Philip Schneider, MS
`
`Keywords: Biosimilars, pharmacoeconomics, affordability
`and access, managed care, payers, benefit management
`
`INTRODUCTION
`Biosimilars are similar versions of originator biologics.
`Biologics are complex molecules that are manufactured using
`living cells and used in the treatment of several chronic inflam-
`matory diseases and cancer. Access to biologics is limited,
`and the availability of biosimilars has the potential to provide
`additional biologic drug options and to decrease the overall
`cost burden to the health care system.1,2 The European Union
`(EU) pioneered the establishment of a regulatory pathway for
`the development and approval of biosimilars, with the first
`biosimilar approved in 2006. To create a regulatory pathway
`for biosimilars in the U.S., Congress passed the Biologics Price
`Competition and Innovation Act of 2009 (BPCIA), authorizing
`the Food and Drug Administration (FDA) to implement an
`abbreviated regulatory pathway (i.e., section 351(k) under the
`Public Health Service Act) for the development and approval of
`biosimilars.1 A biosimilar is defined in the statute as a biologic
`that (1) is “highly similar to the reference product notwithstand-
`ing minor differences in clinically inactive components” and
`(2) has “no clinically meaningful differences” from the refer-
`ence product in terms of safety, purity, or potency.1
`Although biosimilars have been available in the EU for more
`than a decade, the initial market uptake of the products was
`slow.3-5 Many reasons for this have been cited, including a
`lack of provider confidence in these similar biologics, potential
`minor differences from the reference products, uncertainty
`about substitution, certain financial incentives favoring the
`use of originator biologics (e.g., higher reimbursement limits
`for reference biologics), and a lack of patient awareness and
`education.3,5-7 Although uptake has been slow, more than 40
`biosimilars have been authorized for use in the EU, with three
`having been withdrawn.8,9 As of October 10, 2018, 12 biosimilars
`have been approved in the U.S.: filgrastim-sndz (ZARXIO®,
`Sandoz Inc.), infliximab-dyyb (INFLECTRA®, Hospira, Celltrion,
`Inc.), etanercept-szzs (ErelziTM, Sandoz Inc.), adalimumab-atto
`(AMJEVITATM, Amgen Inc.), infliximab-abda (RENFLEXISTM,
`Merck Sharp & Dohme Corp., manufactured by Samsung
`Bioepis Co., Ltd.), adalimumab-adbm (CYLTEZO®, Boehringer
`Ingelheim International GmbH), bevacizumab-awwb (MVASITM,
`Amgen Inc.), trastuzumab-dkst (OgivriTM, Mylan GmbH),
`infliximab-qbtx (IXIFITM, Pfizer Inc), epoetin alfa-epbx
`(RETACRIT®, Hospira), pegfilgrastim-jmdb (FulphilaTM, Mylan
`GmbH), and filgrastim-aafi (NIVESTYMTM, Pfizer Inc., manu-
`
`Mr. Smeeding is at JeSTARx Group in Dallas, Texas; Dr. Malone is at
`the College of Pharmacy at the University of Arizona in Tucson; Drs.
`Ramchandani, Stolshek, and Green are at Amgen Inc. in Thousand
`Oaks, California; and Mr. Schneider is currently at MediHealthIn-
`sight in Scottsdale, Arizona, but was based at the Phoenix Biomedical
`Campus, University of Arizona when this work was completed.
`
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`P&T® • January/February 2019 • Vol. 44 No. 2
`
`factured by Hospira, Inc.) (see Table 1),10-21 although not all of
`them are currently commercially available. More U.S. approvals
`are expected in the near future.
`This review discusses key considerations about biosimilars
`that are relevant to different U.S. payers, including private
`payers (e.g., pharmacy benefit managers [PBMs], private
`insurers) and Medicare perspectives. We explore factors
`promoting the uptake of biosimilars, cost considerations, a
`broader perspective on value beyond price reduction, and the
`current U.S. experience.
`
`UPTAKE OF BIOSIMILARS
`Although acquisition-cost considerations are likely the
`primary factor driving the uptake of biosimilars, additional
`considerations are also important in deciding to select a bio-
`similar over the reference biologic or another biosimilar of
`the same reference biologic (Table 2). For all stakeholders,
`maintaining overall quality, safety, and clinical efficacy is a
`major consideration. Additional considerations for physicians,
`patients, and payers include manufacturer reliability (e.g., the
`dependability of supply without disruptions), reimbursement
`rates set by Medicare or commercial payers, and support ser-
`vices for health care professionals and patients. Many patients
`rely on assurance from their providers about the efficacy and
`safety of their medicines, and also look for ways to reduce their
`out-of-pocket expenses. When considering the selection of a
`biosimilar, PBMs evaluate the contracts, rebates, and supply
`timelines associated with biosimilar use. It is also important to
`consider the impact of patient out-of-pocket expenses on adher-
`ence, as this can affect clinical outcomes. Understanding how
`these factors contribute to the use of biosimilars is important,
`and we seek to address these issues for all stakeholders.
`
`TOTALITY OF EVIDENCE FOR BIOSIMILARS
`To appreciate the challenges and potential of biosimilars,
`it helps to understand the complexities of their develop-
`ment, manufacturing, and regulatory approval. The regula-
`tory review process for biosimilars is based on the totality of
`evidence generated to support the claim of biosimilarity.22,23
`The successful biosimilar development program is designed
`to minimize potential differences between the proposed
`
`Disclosure: Mr. Smeeding reports no competing interests in regard
`to this article. Dr. Malone has received remuneration for consult-
`ing services unrelated to this paper and topic from Amgen Inc.,
`AstraZeneca, Astellas, GlaxoSmithKline, Mallinckrodt, and Sanofi.
`Mr. Schneider is advisory board chair for the Alliance for Safe Biologic
`Medicines. Drs. Ramchandani, Stolshek, and Green are employees of
`Amgen Inc. and own Amgen stock. Editorial support was provided by
`Miranda Tradewell, Meghan Johnson, and James Balwit from Complete
`Healthcare Communications, LLC (North Wales, PA), a CHC Group com-
`pany, whose work was funded by Amgen Inc. under the guidance of
`Dr. Ramchandani (Amgen Inc.).
`
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`Biosimilars: Considerations for Payers
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`Infliximab-dyyb
`
`INFLECTRA®
`
`Etanercept-szzs
`
`Erelzi™
`
`Adalimumab-atto
`
`AMJEVITA™
`
`Infliximab-abda
`
`RENFLEXIS™
`
`Table 1 Biosimilars Approved in the United States14-16,18-21,87-91
`Nonproprietary Name
`Trade Name
`Indication
`ZARXIO®
`• Decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiv-
`Filgrastim-sndz
`ing myelosuppressive anti-cancer drugs
`• Reduce the time to neutrophil recovery and the duration of fever following chemotherapy
`• Reduce the duration of neutropenia and neutropenia-related clinical sequelae in patients
`with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone
`marrow transplantation
`• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection
`• Reduce the incidence and duration of sequelae of severe neutropenia in symptomatic
`patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
`• Crohn’s disease
`• Pediatric Crohn’s disease
`• Ulcerative colitis
`• Rheumatoid arthritis
`• Ankylosing spondylitis
`• Psoriatic arthritis
`• Plaque psoriasis
`• Rheumatoid arthritis
`• Polyarticular juvenile idiopathic arthritis
`• Ankylosing spondylitis
`• Rheumatoid arthritis
`• Juvenile idiopathic arthritis
`• Psoriatic arthritis
`• Ankylosing spondylitis
`• Adult Crohn’s disease
`• Ulcerative colitis
`• Plaque psoriasis
`• Crohn’s disease
`• Pediatric Crohn’s disease
`• Ulcerative colitis
`• Rheumatoid arthritis
`• Ankylosing spondylitis
`• Psoriatic arthritis
`• Plaque psoriasis
`• Rheumatoid arthritis
`• Juvenile idiopathic arthritis
`• Psoriatic arthritis
`• Ankylosing spondylitis
`• Adult Crohn’s disease
`• Ulcerative colitis
`• Plaque psoriasis
`• Metastatic colorectal cancer
`• Nonsquamous non–small-cell lung cancer
`• Glioblastoma
`• Metastatic renal cell carcinoma
`• Cervical cancer
`• HER2-overexpressing breast cancer
`• HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
`• Crohn’s disease
`• Pediatric Crohn’s disease
`• Ulcerative colitis
`• Rheumatoid arthritis
`• Ankylosing spondylitis
`• Psoriatic arthritis
`• Plaque psoriasis
`
`Adalimumab-adbm
`
`CYLTEZO®
`
`Bevacizumab-awwb
`
`MVASI™
`
`Trastuzumab-dkst
`
`Infliximab-qbtx
`
`Ogivri™
`
`IXIFI™
`
`
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`
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`table continues
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`Biosimilars: Considerations for Payers
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`Pegfilgrastim-jmdb
`
`Fulphila™
`
`Table 1 Biosimila