Navigating Biosimilars CHS Pharmacy Education Series ProCE, Inc. www.ProCE.com 1 2017 Pharmacy Education Series February 15, 2017 Navigating Biosimilars Featured Speakers: Ali McBride, PharmD, MS BCPS, BCOP Sue V. Ie, PharmD Clinical Coordinator Hematology/Oncology Fellow, Health Information and Clinical Outcomes Department of Pharmacy Community Health Systems Professional Services Corporation The University of Arizona Cancer Center 2 Submission of an online post‐test and evaluation is the only way to obtain CE credit for this webinar Go to www.ProCE.com/CHSRx Webinar attendees will also receive an email with a direct link to the web page Print your CE statement of completion online – Credit for live or enduring (not both) Deadline: March 17, 2017 CPE Monitor (applicable to pharmacists and pharmacy technicians) – CE credit automatically uploaded to NABP/CPE Monitor upon completion of post‐test and evaluation (user must complete the “claim credit” step) Online Evaluation, Self-Assessment and CE Credit Attendance Code Code will be provided at the end of today’s activity
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Navigating BiosimilarsCHS Pharmacy Education Series
ProCE, Inc.www.ProCE.com 1
2017 Pharmacy Education Series
February 15, 2017Navigating Biosimilars
Featured Speakers:
Ali McBride, PharmD, MS BCPS, BCOP Sue V. Ie, PharmDClinical Coordinator Hematology/Oncology Fellow, Health Information and Clinical OutcomesDepartment of Pharmacy Community Health Systems Professional Services CorporationThe University of Arizona Cancer Center
2
Submission of an online post‐test and evaluation is the only way to obtain CE credit for this webinar
Go to www.ProCE.com/CHSRx
Webinar attendees will also receive an email with a direct link to the web page
Print your CE statement of completion online– Credit for live or enduring (not both)
Deadline: March 17, 2017
CPE Monitor (applicable to pharmacists and pharmacy technicians)– CE credit automatically uploaded to NABP/CPE Monitor upon completion of post‐test and
evaluation (user must complete the “claim credit” step)
Online Evaluation, Self-Assessmentand CE Credit
Attendance Code
Code will be provided at the end of today’s activity
Navigating BiosimilarsCHS Pharmacy Education Series
ProCE, Inc.www.ProCE.com 2
How to Ask a Question
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Navigating BiosimilarsCHS Pharmacy Education Series
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2016 Pharmacy Education Series
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It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. McBride has served in an advisory role for Pfizer and as a speaker for Sandoz. Dr. Ie does not have any relevant commercial and/or financial relationships to disclose.
Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.
February 15, 2017Navigating Biosimilars
Featured Speakers:
Ali McBride, PharmD, MS BCPS, BCOP Sue V. Ie, PharmDClinical Coordinator Hematology/Oncology Fellow, Health Information and Clinical OutcomesDepartment of Pharmacy Community Health Systems Professional Services CorporationThe University of Arizona Cancer Center
CE Activity Information & Accreditation
ProCE, Inc. (Pharmacist and Pharmacy Technician CE)
– 2.0 contact hours
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Funding:This activity is self‐funded through CHSPSC.
Navigating BiosimilarsCHS Pharmacy Education Series
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Biosimilars: A Brief Review of Therapies in Treatment
ALI MCBRIDE, PHARMD, MS BCPS, BCOP
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Learning Objectives
1. Summarize the current Biosimilar Arena
2. Review the clinical data regarding new biosimilars on the market
3. Evaluate FDA Guidance on Biosimilar Interchangeability and Naming
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What Is a Biologic?
A biological product that is demonstrated to be “highly similar” to an FDA‐licensed biological product (reference product)
May rely on certain existing scientific knowledge about the safety, purity, and potency of the reference product
New licensure pathway permits a “biosimilar” biological product to be licensed based on less‐than‐full complement of product‐specific, nonclinical and clinical data
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What Is a Biologic?Technical definition from US Code of Federal Regulations◦ “Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man"
Derived from living sources◦ Various cultures of bacteria or viruses◦ Human or animal sources
Biologics do not always have therapeutic intent
For now, think of biologics as “therapeutic proteins”
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Biologic ProductionProcess important for biologics production
Production process for biologics has more steps and is more complex than process for traditional drugs
HTTP://BIOSIMILARSOURCE.COM/BIOSIMILARS.HTM
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Generic Equivalents as Defined in the “Orange Book”
FDA stipulates that “pharmaceutically equivalent” drug products must be formulated to:◦ Contain the same amount of active ingredient in the same dosage form◦ Meet the same or compendial or other applicable standards (i.e., strength, quality, purity, and identity)
Products are therapeutic equivalents only if:◦ They are pharmaceutical equivalents◦ They can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling
FOOD AND DRUG ADMINISTRATION. CENTER FOR DRUG EVALUATION AND RESEARCH. ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC
EQUIVALENCE EVALUATIONS.12
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General Classes of Biologics
Monoclonal antibodies
Complex sugars
Blood derivatives
Vaccines
Recombinant or purified proteins, such as: ◦ Cytokines◦ Thrombolytic agents◦ Enzymes
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Biologic Manufacturing Process Changes
Despite these differences, when the products are within a prespecified acceptable range, the products are marketed with no change in label
If large alterations occur, analytical studies (and possibly additional clinical studies) are required to compare post‐change product with existing pre‐change product
Schiestl M, et al. Nat Biotechnol. 2011;29:310‐312.
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ICH Q5E: Regulatory Guidance for Changes in Manufacturing of Biologics
Over the life of a biopharmaceutical changes are inevitably introduced into manufacturing◦ Improve yield
◦ Changes in sourcing of components
◦ Changes in production scale
Manufacturing changes are governed by ICH Q5E regulation recognized by both the FDA and EMA. ◦ Guidance aims to minimize the drift inherent in a reference product
◦ The regulations provide guidance to conduct a comprehensive assessment on the impact to the product
Key requirements include:◦ Analytics should be selected and optimized to maximize the likelihood of detecting potential differences
◦ Apply more than one analytical procedure to evaluate the same quality to maximize the detection of potential differences
◦ Evaluate critical control points in the manufacturing process that affect product characteristics
US Food and Drug Administration. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product. Nov 2016 Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
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Biologic Manufacturing Changes –Demonstration of Comparability
FDA. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073476.pdf. Accessed Nov 2016
“The demonstration of comparability does not necessarily mean that the quality attributes of the pre‐change and post‐change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product.”
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Regulatory Pathways for Drugs and Biologics
Li EC, et al. J Manag Care Spec Pharm. 2015;21(7):532‐39 17
Biosimilar Development Approach
Adapted from McCamish M et al. Clin Pharmacol Ther. 2012; 91:405‐17.
Develop highly similar biologic
Test and confirm Interchangeability
Postmarketing Monitoring
Test and confirm biosimilarity
• Analytical methods for structure/function
• Cell lines• In vitro/vivo models• Substance pilot and final scale
• Formulation and final drug product
• Human clinical trials• Consideration of clinically sensitive endpoints
• Clinically sensitive patient population
• Immunogenicity• Efficacy and safety
• No explicit FDA guidance• Will be “difficult” to do in the initial 351(k) application
• Assessment of rare but serious adverse effects
• Active and/or passive surveillance methods
• Follows previous guidance
FDA Approval
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Biosimilar and Biologic Development
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM292463.pdf. Feb 15, 2012 (accessed 2015 Oct 30).
351(a)
351(k)
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Four Assessments of Analytical Characterization
http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. April 2015 (accessed 2015 Oct 30).
Studies of Structure and Function:Residual Uncertainty
Not similar
Similar
Highly similar
Highly similar with fingerprint‐like similarity
No further development through 351(k)
Additional information needed: analytical,
comparative PK/PD, etc.
High confidence; appropriate for targeted clinical studies
Very high confidence; appropriate for moretargeted clinical studies
High
Low
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Human Pharmacokinetics and Pharmacodynamics
“Fundamental” for demonstrating biosimilarity
Both PK and PD will be necessary
◦ PK: patient population considerations
◦ PD should study measures that
◦ Are relevant to clinical outcomes
◦ Can be quickly assessed with precision
◦ Have the sensitivity to detect clinically meaningful difference
Ideally correlate exposure to clinical outcomes
Use crossover and parallel designs
http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. April 2015 (accessed 2015 Oct 30).21
Comparative Clinical Studies
Efficacy and safety: specific clinical trial design will depend on what residual questions remain◦ Clinical studies should be designed to demonstrate neither decreased nor increased activity
◦ Use clinically relevant and sensitive endpoints in the right population
◦ Biosimilar sponsor to justify comparability delta
Schellekens H. NDT Plus. 2009; 2(suppl 1):i27‐i36.22
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Indication Extrapolation Framework
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142358.pdf (accessed 2015 Nov 4).
Weise M et al. Blood. 2014; 124:3191‐6.
Patient Factors• Similarity of biologic disposition: PK/PD
• Single vs. combo therapy• Clinical manifestation
Endpoint Factors• Efficacy and toxicity• Short‐term vs. long‐term
• Sensitivity of surrogate outcomes
Quantitative Evidence of BiosimilarityIn vitro, preclinical, epidemiological studies, diagnostic studies, clinical trials, and
observational studies
Indication Extrapolation DeterminationNo extrapolation; extrapolation to some indications; extrapolation to all indications
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Source of Names and NumbersOriginator Manufacturer ◦ Reference Product (Trade Name)
• United States Adopted Names (USAN)◦ The generic name (Reference Name)◦ Provided by AMA◦ Generally adopted by FDA
United States Pharmacopeia (USP)◦ Monographs and consistency concerns
Institute for Safe Medication Practices (ISMP)◦ Consults on Naming Clarity and Safety concerns ◦ Advocates for Labeling standards
Food and Drug Administration (FDA)◦ Ultimately approves product name◦ Assigns National Drug Code (NDC)
Centers for Medicare & Medicaid Services (CMS) ◦ Assigns HCPCS codes ◦ Codes usually the same between biosimilars & originator
HCPCS=Healthcare Common Procedure Coding System 24
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The Dilemma of Biosimilar Naming
Biosimilars should have the exact same INN as the reference product
Biosimilars should have a distinct INN to differentiate from reference
and other biosimilars
Pros• Communicate that these products are “highly similar”
• Facilitate adoption and substitution of interchangeable biologics
Cons• Hard to trace for pharmacovigilance
Pros
• Improved pharmacovigilance• Recognize as distinct productsCons
• Confusion about whether they are “interchangeable”
• May impede adoption• Issues with substitution
Traynor K. Am J Health‐Syst Pharm. 2014; 71:446‐7.
Carroll J. Manag Care. 2013; 22:6‐7.25
Importance of a Naming StrategyGoal:
◦ Identify relationship between the “biosimilar” and “reference” / “originator”◦ Therapeutic category
◦ Dosing ◦ Differentiate products
◦ Support pharmacovigilance (PV)
◦ Intended product administered to patient
◦ Outcomes and ADEs attributed to correct product
◦ Avoid “sound alike” and “look alike” errors
◦ Facilitate effective product “track and trace” (anti‐counterfeiting)
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Biosimilar Naming
FDA PROPOSED SUFFIX FDA PROPOSED SUFFIX
UniqueDevoid of meaningFour lowercase letters of which at least three are distinctNonproprietaryAttached to the core name with a hyphenFree of legal barriers that would restrict its usage
Be false or misleadingInclude numerals and other symbols aside from the hyphen attaching the suffix to the core nameInclude abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or orderContain or suggest any drug substance name or core namelook similar to or be capable of being mistaken for the name of a currently marketed product Look similar to or otherwise connote the name of the license holderBe too similar to any other FDA-designated nonproprietary name suffix
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Naming OptionsOptions◦ Totally different names from originator
◦ Preferred by most originator pharmaceutical companies
◦ Same USAN name as originator
◦ EU policy
◦ Unique suffix attached to originator’s USAN
◦ Error prone because some computer fields truncate long names
◦ Facilitates listing adjacent to reference in formulary data bases
◦ Supported by WHO, ISMP, HOPA
◦ Unique prefix attached to originator’s USAN
◦ Precedent with tbo‐filgrastim
◦ Current FDA position
◦ Open comment period on using meaningful suffix
◦ Current precedent for 2 Sandoz products:
◦ Filgrastim‐sndz Zarxio ®
◦ Etanercept‐szzs Erelzi ®
◦ Infliximab‐dyyb Inflectra ®
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FDA Draft Guidance on Naming
Goal: facilitate pharmacovigilance and prevent inadvertent substitution
INN with an added random four‐letter suffix for all biologics (including reference products)◦ replicamab‐cznm
◦ replicamab‐hixf
Benefits◦ Common INN will group similar biologics in electronic systems
◦ Having suffix for all products reduces perception that biosimilar is inferior to reference product
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
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 alteration or switch
A product with an interchangeable designation may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product
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Biosimilar Implementation
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Biosimilar Pharmacovigilance
Zuñiga L et al. Pharmacoepidemiol Drug Saf. 2010; 19:661‐9. Felix T et al. Nat Biotechnol. 2014; 32:128‐30. Casadevall N et al. Expert Opin Biol Ther. 2013; 13:1039‐47.
Pharmacovigilance
• Practical to encourage healthcare provider reporting
• Real‐time data
• Ensure traceability
Risk minimization
• Healthcare provider communication
• Recalls and alerts
• FDA REMS?
Risk Identification andCharacterization
FDA Approval
Healthcare Provider Responsibility for Reporting• Correct attribution of safety event• Maintenance of electronic medical record• Bar code administration• Medication reconciliation• Consideration of transitions of care
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The P&T Committee Will Be Integral to the Biosimilar Implementation Process1
The review process will be different than that used for a generic small‐molecule drug
P&T Committees will likely establish institutional policies around therapeutic substitution
1. Zelenetz AD, Ahmed I, Braud EL, et al. JNCCN J Natl Compr Cancer Netw. 2011;9(SUPPL. 4). 37
Considerations for Formulary Selection of Biosimilars
Griffith N et al. Hosp Pharm. 2014; 49:813‐25.
• Clinical data• Range of
indications• Immunogenicity
concerns• Potential for
therapeutic interchange
• Number of similar agents on formulary
• Pharmaco‐vigilance requirements
• Supply reliability• History of drug
shortages• Supply chain
security• Anti‐counterfeit
measures• Patient assistance
programs• Reimbursement
support
• Product packaging and labeling
• Bar coding • Compatibility
with CSTDs,* robotics
• Product preparation and administration
• Storage requirements
• Economic considerations Hospital Payer Patient
• Payer policies• Transitions of care• IT and medication
system changes• Educational
requirements
Efficacy/SafetyManufacturer Considerations
Product Considerations
Hospital and Patient Factors
*CSTDs = closed system transfer devices
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Formulary Selection Considerations:Efficacy and Safety
Clinical data and populations studied in FDA approval
Range of indications
Presence of biomarker to assess efficacy and safety
Experienced vs. de novo patients◦ Immunogenicity concerns due to switching
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7‐5‐2016 US Federal Court (Amgen vs Apotex) requires biosimilar manufacturer to give notice to reference manufacturer and wait 180 days before bringing the drug to market.
Drug (examples) Patent Expires
Lovenox 2012
Neupogen 2013
Epogen 2013
Lantus 2014
Interferon beta 1‐a 2015
Neulasta 2015
Synagis 2015
Humira 2016
Rituximab 2016
Erbitux 2016
Remicade 2018
Avastin 2019
Herceptin 2019
Aranesp 2024
Etanercept (Enbrel) approved 9‐2016, delayed market release to 3‐2017
Applies to each originator biological product, related biological product, and
biosimilar product
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FDA releases nonproprietary
naming guidance for biologics,
Jan. 2017
Core name
Four lowercase
letter suffix**
Proper name
**unique, devoid of meaning, four lowercase letters of which at least three are distinct, nonproprietary, attached to the core name with a hyphen, and free of legal barriers that would restrict its usage
– Meets the standards in section 351(k)(4) of the PHS Act and may be substituted for the reference product without the intervention of the HCP who prescribed the reference product
• FDA requirements for interchangeability will vary based on the product submitted, including:
– Product complexity
– Product‐specific immunogenicity risk
• Switching studies
– Used to determine whether alternating between a biosimilar and its reference product two or more times impacts the safety or efficacy of the treatment course
– Not needed if product only intended to be administered once
• Extrapolated data may be used to support interchangeability for multiple indications if there is adequate scientific justification to do so
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Obstacles to Biosimilar
Adoption in the U.S.
• Extensive and continuous education needed
• Reimbursement is complicated and varies widely
• Information systems will require tweaks to signify
originator biologic vs biosimilar products
• Patent loading and “patent dance” by pharmaceutical
companies
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BIOSIMILARSFORMULARY STATUS
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Guidance for Use of
Inflectra®
• CHSPSC, LLC Formulary Management
Committee physicians have recommended
Inflectra Category A status
• Equal availability of both Inflectra
and Remicade to acute care, outpatient
infusion centers, and physician practices
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Guidance for Use of
Inflectra®
Establish processes within your
business offices that when clinically
appropriate as assessed by the prescriber (Physician Practice) and/or
medical staff (Acute Care), to evaluate
the prior authorization
requirements for Inflectra and
Remicade and consider these in
determining prescribing, especially in
qualifying new patient starts
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Biosimilars –CHSPSC
Formulary Status
• Zarxio and Inflectra do NOT have interchangeable
status
Biosimilar ReferenceProduct
CHSPSC Formulary Status
Zarxio® (filgrastim‐sndz)
Neupogen(filgrastim)
Category B
Inflectra® (infliximab‐dyyb)
Remicade(infliximab)
Category A
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Inflectra vs. Remicade
Formulary Assessment
• Same dosage forms and strengths available
• Same indications with exception of pediatric ulcerative
colitis due to market exclusivity for Remicade for that
indication until September 2018
• Same dosing and drug interactions
• Similar efficacy and adverse effects expected
• Similar patient assistance programs
Inflectra Category A formulary status recommended
Both Remicade and Inflectra available—perform local reimbursement assessment
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REIMBURSEMENT AND BILLING OF
BIOSIMILARS
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Coverage for Inflectra
• Coverage varies across commercial payers, Medicare,
and Medicaid and by treatment site of care
• Providers should confirm payer policies prior to
treating patients with Inflectra
Confidential CHS‐specific costs are available on the CHSPSC Corporate Pharmacy intranet and through your local Regional Pharmacy Directors. These may be used locally in your determinations.
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As a reminder, OPPS claims for separately paid biosimilar biological products are required to include a modifier that identifies the manufacturer of the specific product. The modifier does not affect payment determination, but is used to distinguish between biosimilar products that appear in the same HCPCS code but are made by different manufacturers.
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Controversial CMS Payment Policy
• Coding
– All biosimilars sharing the same reference product
will have a single billing and payment code, or Q‐
code
– Biosimilars are required to have a modifier
designating the product and the manufacturer,
e.g., Inflectra = Q5102/ZB
• Reimbursement
– Single payment rate for all biosimilars by blending
the volume‐weighted Average Sales Price (ASP) for
each biosimilar and 6% of the reference product’s
ASP
– Same model as for multi‐source generic drugs
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Controversial CMS Payment Policy
• Issues and concerns with this
methodology
– Biosimilars are single‐source drugs and
fundamentally different from generics
– Conflicts with the BPCIA of 2009 and the
351(k) abbreviated licensure pathway
– Potentially misleading since biosimilar
products can have different approved
clinical indications
– Modifier inadequate for distinguishing
between approved clinical indications
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Form Locator (FL) 42. Specify revenue codes FL 44.Specify appropriate CPT and HCPCS codes and moifiers, including, the “ZB” HCPCS modifier to specify Inflectra
FL 46. Specify the units. For example, 10 units = 100 mg of infliximab biosimilar (Inflectra). To bill 400 mg, enter 40 units
As of January 2017, 38 states have considered establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product.
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While the FDA considers naming and traceability, also consider proactive changes to ADR reporting requirements to minimize and proactively address these concerns.
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Immunogenicity of Remicade and
Inflectra
• Infliximab and biosimilar infliximab‐dyyb
demonstrated similar incidence of antidrug antibodies