MAIN MENU

BACK

BACK

  • Home

  • About
  • News & Events
  • Careers
  • Countries
  • Contact Us
  • Volunteer
  • PAREXEL Academy
  • Partners
  • Client Login
Explore PAREXEL
  • JourneyGO
  • SolutionsGO
  • ExperienceGO
  • Outsourcing ModelsGO
  • Planning
  • Phase I
  • Phase IIa
  • Phase II-III
  • Phase IIIb-IV
  • Post Launch
  • Clinical Research
    • Early Phase Services
      • Dedicated Therapeutic Expertise
        • Early Phase and Late Phase integrated study management
      • Patient Populations
      • Strategic Locations
        • Berlin
          • Virtual Tour
        • London
          • Virtual Tour
        • Baltimore
          • Facility
          • Virtual Tour
        • Los Angeles
          • Virtual Tour
      • Phase 1, First in Human
        • Ethnobridging for Accelerated Global Drug Development
      • Phase IIa, Proof of Concept
      • Early Product Development
      • Ethnobridging
      • Clinical PK/PD and Pharmacometrics Services
        • Case Study: Safety/Pharmacovigilance #1
        • Case Study: Safety/Pharmacovigilance #2
      • Bioanalytical and Biomarkers
      • Bioequivalence Studies
      • Volunteer to Participate
    • Phase II-III Services
      • Phase III
        • Case Study: Chronic Renal Failure
        • Case Study: Expanded Access Program
        • Case Study: Accelerating development in global COPD trials
      • Medical Writing and Submission
      • Feasibility and Enrollment
        • Patient Recruitment
          • Case Study: Pediatric Migraine Patient Recruitment
        • Country and Site Selection
        • Alliance Site Strategy
        • Protocol Optimization
    • Phase IIIb-IV
    • ForeSite™ Clinical Trial Methodology
      • Study Design
      • Study Start-Up
      • Study Execution
    • Global Data Operations
      • Clinical Data Management
      • Biostatistics Services
      • Clinical MetaData Repository (MDR)
    • Medical Writing Solutions
    • Quantitative Clinical Development Services
    • Clinical Trial Supplies & Logistics
      • Global Reach
      • Clinical Trial Supplies
      • Ancillary Supplies
      • Laboratory Logistics and Biological Sample Lifecycle Management Services
      • Randomization and Trial Supply Management
      • Cold Chain Logistics
      • Clinical Trial Supply Chain - Active Tracking
    • Customer Care Services
    • Genomic Medicine Services
    • Clinical Adjudication Services
  • Informatics
    • Regulatory and Clinical Technology
      • Regulatory Information Management
        • LIQUENT InSight®
        • Regulatory Cloud
        • Regulatory Outsourcing Services
      • Data-Driven Monitoring
      • Clinical Trial Management System (CTMS)
        • IMPACT® CTMS Software
      • Electronic Data Capture
        • DataLabs® EDC
      • MyTrials® Analytics
    • Patient Technology
      • Randomization and Trial Supply Management
        • Clinical Trial Supplies & Logistics
        • Clinical Trial Supply Chain - Active Tracking
        • ClinPhone RTSM Mobile App
      • Medical Imaging
        • Therapeutic Expertise
          • Oncology Imaging Expertise
            • Criteria Experience
              • 1996 NCI-WG CLL
              • IWCLL 2008
                • Key Topics: IWCLL 2008
                  • Definitions
                  • Usable Criteria to Evaluate
                  • Target Sites of Disease
                  • Non-Target Sites of Disease
                  • Organomegaly
                  • New Lesions
                  • B symptoms
                  • Blood Counts
                  • Bone Marrow
                  • Transformation
                  • Role of Imaging in CLL Clinical Trials
                  • Clinical Data Assessments
              • 1999 IWG-NHL
              • 2007 IWG-NHL
                • Key Topics: 2007 IWG-NHL Assessment Criteria
                  • Definitions
                  • Usable Criteria to Evaluate
                  • Target Sites of Disease
                  • Non-Target Sites of Disease
                  • Organomegaly
                  • New Lesions
                  • Bone Marrow
                  • Other Laboratory Values and Symptoms
                  • Incorporation of FDG-PET
                  • Defining Normal, Abnormal and Measurable
                  • Problem with CRu
              • RECIST
          • Neurology Imaging Expertise
          • Musculoskeletal (MSK) Imaging Expertise
          • Women's Health Imaging Expertise
          • Dermatology Imaging Expertise
          • Gastroenterology Imaging Expertise
          • Ophthalmology Imaging Expertise
          • Volumetric Imaging Expertise
          • Cardiovascular Imaging Expertise
        • Imaging Services
        • Scientific Advisors
        • Consultation
        • Advanced Medical Imaging
          • Cloud-Based Solutions for Sites
      • Patient Sensors
      • Electronic Clinical Outcome Assessments (eCOA)
        • ePRO (electronic Patient Reported Outcomes)
        • Clinical Outcome Assessments Consulting
    • Clinical Trial Supplies & Logistics
    • Perceptive® Cloud
    • Asset Transfer Services
    • PAREXEL's Education Services
      • IMPACT® CTMS Training
      • LIQUENT InSight® Training
        • Courses & Registration
          • LIQUENT InSight® for Submission Management
            • LIQUENT InSight®Submission Planning and Tracking
          • LIQUENT SmartDesk™
            • Automating the Publishing Process with LIQUENT SmartDesk™ for PDF
          • LIQUENT InSight for Viewing
            • Reviewing Submissions with LIQUENT InSight® for Viewing
        • Training Resources
      • DataLabs® EDC Training
      • Perceptive MyTrials® Training
      • Data-Driven Monitoring Training
      • Certification Programs
      • Other Training Services
    • Customer Care Services
  • Consulting
    • Integrated Product Development
      • A Biosimilar Milestone with Implications
    • Regulatory Compliance & Risk Management
      • Q&A about GCP
        • Quality By Design Putting Theory Into Practice
      • Strategic Compliance: Data Integrity
      • FDA 483s: Your Questions Answered
      • Important Reminder About PET (Positron Emitting Topography) FDA Regulations
      • Quality By Design Putting Theory Into Practice
    • Regulatory Outsourcing Services
      • eCTD
    • Clinical Trial Regulatory Services
    • Regulatory Information Management & IDMP Solutions
      • IDMP Readiness Assessment
      • IDMP Task Force Updates
        • November 2015 Task Force Meeting
    • Market Access Consulting
  • Access
    • Real World Evidence
      • Late Phase Clinical Operations
        • Late Phase Interventional Trials
        • Observational Research
        • Epidemiology
        • Expanded Access Programs
        • Clinical Outcome Assessment (COA)
          • Case Study: Health Economics
          • Outcomes Research
      • Real World Data Services
    • Drug Safety Services
      • Risk Management / REMS
    • Market Access Consulting
      • Commercial Decision Pathways
      • Evidence Generation
        • Evidence Review and Meta-Analysis
          • Evidence Review Options
          • Evidence Review Resources
        • Health Economic Modeling
        • Global and AMCP Value Dossiers
        • Manuscripts and Posters
        • Data Analytics
        • Strategic Communications
      • Access Realization
        • Pricing, Reimbursement and Market Access Expertise
        • List of Services: Pricing, Reimbursement and Market Access
    • Medical Communications
      • Communication Strategy
      • Publications Planning and Scientific Content
      • Expert Identification and Engagement
      • Global Study Engagement
      • Branding and Creative Strategy
      • Digital Media and Video Solutions
      • Live and Virtual Events
      • Payer Communication
      • Editorial and Production
    • Outsourced Field-Based Medical Teams
  • Therapeutic Expertise
    • Oncology
    • Cardiovascular & Metabolic Diseases
    • Central Nervous System (CNS) Disorders
    • Infectious Disease
    • Respiratory Capabilities
    • Rheumatology & Immunology Capabilities
    • Rare Diseases
  • Industry Expertise
    • Pharmaceuticals
      • Biosimilar Consulting
    • Medical Devices
    • Biologics
    • Biosimilars
      • Biosimilar Video
  • Regulatory Expertise
  • Market Access Expertise
  • Global Presence
    • North America
    • South America
    • Europe
    • Asia
    • Middle East & Africa
    • Emerging Markets
  • Strategic Partnerships
  • ExecuPharm Functional Service Solutions
  • PAREXEL® BioPharm Unit
  • About
  • News & Events
  • Careers
  • Countries
  • Contact Us
  • Volunteer
  • PAREXEL Academy
  • Partners
  • Client Login
  • Journey
    • Planning
    • Phase I
    • Phase IIa
    • Phase II-III
    • Phase IIIb-IV
    • Post Launch
  • Solutions
    • Clinical Research
      • Early Phase Services
      • Phase II-III Services
      • Phase IIIb-IV
      • ForeSite™ Clinical Trial Methodology
      • Global Data Operations
      • Medical Writing Solutions
      • Quantitative Clinical Development Services
      • Clinical Trial Supplies & Logistics
      • Customer Care Services
      • Genomic Medicine Services
      • Clinical Adjudication Services
    • Informatics
      • Regulatory and Clinical Technology
      • Patient Technology
      • Clinical Trial Supplies & Logistics
      • Perceptive® Cloud
      • Asset Transfer Services
      • PAREXEL's Education Services
      • Customer Care Services
    • Consulting
      • Integrated Product Development
      • Regulatory Compliance & Risk Management
      • Regulatory Outsourcing Services
      • Clinical Trial Regulatory Services
      • Regulatory Information Management & IDMP Solutions
      • Market Access Consulting
    • Access
      • Real World Evidence
      • Drug Safety Services
      • Market Access Consulting
      • Medical Communications
      • Outsourced Field-Based Medical Teams
  • Experience
    • Therapeutic Expertise
      • Oncology
      • Cardiovascular & Metabolic Diseases
      • Central Nervous System (CNS) Disorders
      • Infectious Disease
      • Respiratory Capabilities
      • Rheumatology & Immunology Capabilities
      • Rare Diseases
    • Industry Expertise
      • Pharmaceuticals
      • Medical Devices
      • Biologics
      • Biosimilars
    • Regulatory Expertise
    • Market Access Expertise
    • Global Presence
      • North America
      • South America
      • Europe
      • Asia
      • Middle East & Africa
      • Emerging Markets
  • Outsourcing Models
    • Strategic Partnerships
    • ExecuPharm Functional Service Solutions
    • PAREXEL® BioPharm Unit
  • Company
    • Management Team
      • Jamie Macdonald
      • Roland Andersson, Ph.D.
      • Michael Crowley
      • Xavier Flinois
      • Michele Fournier
      • David J. Godwin
      • Simon Harford
      • Sy Pretorius, M.D.
      • Gadi Saarony
    • News & Events
      • Press Releases
      • Events
      • Webinars
      • 12th Annual Partnerships in Clinical Trials Congress
      • Archived PAREXEL in the News
    • Find an Office
    • Careers
      • Careers at PAREXEL®
      • CEO Message
      • Find Your Path - Opportunities
      • University Graduates – Opportunities for students
    • Volunteer
      • About Us
      • Locations Worldwide
      • About Clinical Trials
      • Why Participate?
      • FAQs
      • Glossary
    • Sustainability
      • Consumption Trend Analysis
    • Code of Conduct
    • eClinical Innovation
    • Purchasing
      • Purchase Order Terms and Conditions
      • Bedingungen für den Kaufauftrag
      • Vigente desde el
      • PO Terms - Japanese
      • PO Terms - Chinese 'S'
      • PO Terms - Chinese 'T'
      • Ordem de Compra Termos e Condições
    • Contact Us
      • Thank You
    • Partners
      • Service Partners
      • Training Partners
      • Technology Partners
      • Referral Partners
      • Accredited Partner Program
    • PAREXEL Reports U.K. Gender Pay Data
  • Perceptive®
  • User Group Meeting
    • IMPACT CTMS User Group Meeting Details and Agendas
    • IMPACT CTMS User Group Meeting Justification Letter
    • Meeting Registration and Hotel Details
    • Benefits for attending the IMPACT CTMS User Group Meeting
    • Registration Rates
    • Hotel Rates
  • Horizons
    • About
    • Locations
    • FAQs
    • Agenda
  • RWE Symposia
    • About
    • Locations
    • FAQs
    • Agenda
  • Graduate | PAREXEL
    • Culture at PAREXEL
    • Former Trainees at PAREXEL
      • Career Trainee Meghan
      • Career Trainee Sam
    • Great Place to Work
    • PAREXEL Overview
    • Clinical Trainee Program Belgium
    • Clinical Trainee Program Japan
    • Graduate Scheme India
    • Clinical Research Awards
    • Graduate Scheme UK
  • parexel-insights
    • When It Comes to CTMS One Size Does Not Fit All
    • This Disease Will Not Win the Fight
    • Designing Trials Payers Can Trust
    • Utilizing Secondary Healthcare Data Assets
    • RIM & IDMP Synergies
    • Clarifying the Criteria that Better Capture Antitumor Activity of Immune Therapeutics
    • 'Now is the time to include Japan' says PAREXEL
    • High Performance Workplace Practices That Attract and Retain Millennials
    • Clinical Trial Feasibility & Patient Enrollment: Differentiation Through Innovation
    • Developing Drugs in the New Era of Personalized Medicines
    • Interview with PAREXEL’s Aida Sabo, About Challenges & Successes in Diversity & Inclusion
    • Imaging Endpoint Selection For Biosimilar Development
    • CONSIDERATIONS IN BIOSIMILARS DEVELOPMENT– A US FDA PERSPECTIVE
    • Protocol Optimization
    • New Approaches to Data Management in Clinical Trials
    • 30 Years Later: Lessons from Living in a Pandemic
    • Why RTSM & IRT stand for Speed, Simplicity & Service
    • PAREXEL’s Training Approach and the Importance of Training a Global Workforce
    • Involved & Engaged: The Last Mile of Business Performance
    • Adaptive Trials: Complex But Advantageous
    • Grateful for Advancements in Medicine
    • The Human Touch: Aligning Reward Systems with Company Strategy and Meaningful Work
    • Orphan Drug Pricing in Europe
    • Generating Evidence to Drive Patient Access
    • Life is Short and Love is Eternal
    • The Complete Journey: Improving Clinical Trials Using Modern Technology
    • A People Strategy Attracts the Best Talent
    • Clinical Development of Next Generation Biologics
    • Best Practices to Improve the IRT Site User Experience
    • If You Never Stop Learning, You Can Never Stop Earning
    • PAREXEL's Connected Journey™ of Data-Driven Services
    • Focused on the Finish Line
    • Using Analytics to Optimize The Clinical Development Process
    • Accelerated Pathways: Global Opportunities & Challenges for Innovators
    • Immuno-Oncology: Past, Present and Future
    • How do eClincal solutions Increase Clinical Trial Efficiency?
    • Successfully Integrating Electronic Health Record and Electronic Data Collection Data
    • How to Maximize Potential and Sidestep Pitfalls of MAPs
    • World Cancer Day: Reflecting on Progress and Hope for Patients
    • Progress in Pursuit of a Cure - World AIDS Day 2017
    • How Performance Reviews Support High-Performance Talent
    • How Protocol Optimization Improves Clinical Trial Outcomes
    • Optimizing the clinical development process with Social, Mobile, Analytics, and Cloud (SMAC)
    • Overcoming Data Capture and Management Challenges
    • Running with a Purpose
    • Three Keys To Mitigating Risk In Adaptive Trials
    • Diversity and Inclusion: This Is How the Best Global Companies Learn, Plan, and Measure Success
    • Dream or Reality- Improving Patient Safety & Reducing Costs?
    • Attitude is Everything
    • Key Considerations In Biologics Clinical Development
    • Dr. Sy Pretorius, Chief Scientific Officer Talks About Adaptive Design Trials
    • Your clinical trial supply may be at risk – Brexit and the impact on IMP distribution
    • Innovation in the Pharmaceutical Industry: A Change Toward Personalized Medicine
    • Recorded Webinar: Getting to Approval Faster Through Technology Innovation
    • Data Management Roles, Process and Technologies in Risk Based Study Execution
    • You’re Hot Then You’re Cold -Temperature Management & RTSM Integration
    • Precision Medicine’s Next Hurdle: Quality Management of Human Samples
    • Navigating Regulatory Submissions
    • Dragons - the Guardians of Disease
    • Shogo Nakamori Discusses Joint Program for Clinical Research
    • Genomic Medicine, Data Modeling and Clinical Trials
    • Recognizing Uncle David
    • Demonstrating Value and Managing Risk Throughout Development
    • Shogo Nakamori Discusses Trends in Drug Development in Japan
    • Increasing Study Predictability
    • On Demand Webinar - The Power of Foresight: Improving Drug Development Performance through Optimized Protocol Design
    • Want Your Business to Thrive? Focus on Developing Your People
    • Anything is Possible
    • PAREXEL Celebrates International Women's Day 2018
    • Get Into Pole Position with Modern IRT Services
    • Drew Garty Discusses Data Driven Monitoring
    • Rooting for Team Jessie
    • Beyond Diversity: What Happens When You Define a Culture of Inclusion
    • Quantitative Modeling For Clinical Trials
    • How to Know You’re Keeping Your (Clinical Trial Supplies) Cool
    • The Next Generation of Talent Management: Opportunities For Diversity
    • Contracting - A Key Component Of A Strong Vendor Relationship
    • Albert Siu, PhD, Explains How PAREXEL Academy Benefits Clients
    • Three Skills Developers Will Need to Thrive in the New Era of Genomic Medicine
    • Aligning on Patient Outcomes – How Market Dynamics Can Facilitate RWD (Real World Data) Solutions in Research
    • Accelerated Pathways and Stock Prices
    • Improving Site Experience with Risk-Based Monitoring
    • Roland Andersson, SVP, Discusses Investing Trends and Emerging Biopharmaceutical Companies
    • Shogo Nakamori Discusses Japan & Multi-national Trials
    • What You Need To Know About Biosimilars Development
    • Wearables Shaping the Future of Clinical Trials
    • Training Compliance is an Increasingly Complex Journey
    • Why Strategy is Not Enough: Building the Bridge From Strategy to Results Requires Organizational Excellence
    • Mergers & Acquisitions: Where’s the Real Finish Line?
    • The Collaborative Advantage of Biopharma Companies and Global Service Providers
    • 3 Principles for a Sound Clinical and Regulatory Document Strategy for Small Biopharmaceuticals
    • Navigating Regulatory Complexities Of Biosimilar Development
    • Josh Schultz, Corp. VP Talks About PAREXEL Access
    • Something Good Always Comes From Something Bad
    • "Yes, I Can!"
    • Working Towards a Glimpse of a Cure
    • World Cancer Day: Breakthroughs and Challenges for Precision Medicine
    • Surveillance or Surgery?
    • Clinical Trial Support Query - Who Ya Gonna Call?
    • Leveraging the Cloud to Accelerate Time to Treatment
    • A Biosimilar Milestone with Implications
    • The Clinical, Regulatory and Commercial Implications of Rapid Approval
    • Biosimilar mAbs – a unique and distinct market (for the time being…?)
    • Accelerated Pathways & Commercial Consequences Forum & Findings
    • WHAT CAN WE LEARN FROM IMMUNO-ONCOLOGY CLINICAL TRIALS?
    • When the Doctor Becomes the Patient
    • Albert Liou Discusses the Drug Development Landscape in Korea
    • Effective Late Stage Pathways For Biosimilar Products
    • How to Simplify Site Tasks and Help Ensure Dispensing Accuracy
    • Medical Writing for Submission to Asia-Pacific Regulatory Authorities
    • The Life of a Human Biological Sample: A Look Inside and How to Maintain Its Integrity
    • The Impact of the Digital Human Resources Organization on People - Part 1
    • The Evolution of Drug Development & Market Access via Connected Data-driven Solutions
    • The Emerging Role of Wearable Devices For Real-World Data Collection
    • Active Tracking Is Out To Reduce Sites’ Workload
    • Ubavka DeNoble Talks About PAREXEL's BioPharm Unit
    • The Journey Continues – I Got This
    • So, My Fitbit is Clinical Trial Grade Right?
    • Latin America’s Role in Clinical Studies
    • Trends in Translational Development
    • Effective use of Value to Achieve Optimal Market Access
    • Three Ways to Mitigate the Risk of Late-stage Failure in CNS Drug Development
    • HOW TO EFFECTIVELY DEVELOP CLINICAL DOCUMENTS IN THE EU/US AND CHINA NDA DOSSIER
    • The Art and Science of Productive FDA Meetings
    • Driving the Digital Transformation of the Industry
    • Regulatory Strategy In Emerging Markets
    • Exploring Our Partnership with CHA Medical Group
    • PAREXEL Introduces Jamie Macdonald as Chief Executive Officer
    • Understanding different stakeholder requirements throughout commercialization
    • Development considerations: Comparing major markets including US, EU, Japan and China
    • Risk and Common Mistakes in Import and Export Documentation for Clinical Trials
    • Operational Aspects Of Independent Reviews for Immune-Oncology Clinical Endpoints
    • PAREXEL Academy Introduces New Collaboration to Develop Japan’s Biopharmaceutical Workforce of the Future
    • The Evolution of Randomization and Trial Supply Management Services
  • agile-IRT
    • Agile IRT
    • Reduced Timelines
    • Simpler Processes
    • Expert Services
    • Contact
  • test
    • Graduate | PAREXEL
  • Menu
Home > parexel-insights > Biosimilar mAbs – a unique a...

Biosimilar mAbs – a unique and distinct market (for the time being…?)

By Richard Macaulay and Matthieu Hugon
November 27, 2017

What are biosimilars?

Biologic therapies are complex, high molecular weight protein-based therapeutics that are manufactured by living organisms. These differ from ‘traditional’ low molecular weight compounds that have been created by chemical synthesis. When low molecular weight medicines lose patent protection, other companies can produce generic versions, which are exact copies of this innovator compound. By contrast, due to their much greater structural and manufacturing complexity, making exact ‘generic’ copies of biologics is virtually impossible. However, what compounds can be produced are termed ‘biosimilars’, biological products that are similar to and have comparable structure and efficacy to a branded reference biological product.

Why are biosimilars receiving so much attention?

Biosimilar versions of various molecules including epoetins, insulins, somatropins, growth hormones, and follitropins have existed for several years in many markets. Recently, interest in biosimilars has exploded with the advent of biosimilar monoclonal antibodies (mAbs). Biologic mAbs represent many of the best-selling, high-cost medicines and as such provide an opportunity for significant payer savings. The Food and Drug Administration (FDA) and European Commission approved their first biosimilar mAbs in 2016 and 2013, respectively, and have approved a total of three and six biosimilars, respectively, as of May 2017.

How do biosimilars receive regulatory approval?

Biosimilars are treated by regulators in a distinct manner, requiring less supportive data for approval than reference biologics (which typically require a full preclinical program and Phase 3 studies in all targeted indications) but more than generic products (where a bioequivalence study forms the key clinical data and no pre-clinical testing is required). Biosimilars require an abbreviated pre-clinical program alongside comparative pharmacokinetic and pharmacodynamic Phase 1 studies and Phase 3 clinical studies. However, a Phase 3 study is not required in all indications, as the marketing authorization may be extrapolated from the first to all subsequent reference product indications.

Once biosimilars are on the market, how are they priced, purchased, and prescribed?

Discounting is obviously a key driver for biosimilar adoption. However, discounts on biosimilar products are typically more limited than discounts on generics due the higher costs of manufacturing, clinical development, and marketing. Typically, generic drugs are deemed interchangeable with the branded originator product and substitution is automatic. By contrast, the decision to use a biosimilar involves multiple stakeholders, and appropriate initiatives must be present to incentivize stakeholders at different decision-making points (Figure 1).

Figure 1: Key points in the decision-making pathway for biosimilar usage

  blog graphic 3.png

Why does biosimilar use vary among major markets?

When a biosimilar receives marketing authorization it can be prescribed by physicians. However, it does not address the key question as to whether a biosimilar may be considered ‘substitutable’ (when a pharmacist can replace the originator biologic with the biosimilar with physician’s consent) or ‘interchangeable’ (when a pharmacist can substitute the biosimilar without physician’s consent, typical of generic products) with its reference biologic.

In the US, the FDA can designate a biosimilar interchangeable, via a process that is more rigorous than that for standard (substitutable) biosimilar approval and which requires additional data. No biosimilar has attained interchangeable status to date. By contrast, in Europe, the European Medicines Agency does not have the authority to designate biosimilars as interchangeable – this rests with the individual member states. In some counties, such as France or Spain, biosimilars are treated akin to innovator products with no interchangeability permitted, whereas in others, such as Germany, they more like generics with automatic substitution encouraged. This variation in treating biosimilars as innovator products or generics also extends to other key domains (Table 1). Some markets (e.g., Germany) have tendering processes for biosimilars (in the same way that they contract generics). Other markets (e.g., France) require biosimilars to be appraised by their Health Technology Assessment body in the same way as a new therapeutic agent, whereas still others (e.g., England) require no appraisal, as in the case of generics. Overall, many markets fall between the two ends of the market access spectrum of being treated ‘like generics’ versus ‘like biologics’ (Figure 2).

Figure 2: Market access spectrum of biosimilar mAbs

blog graphic arrow.png

Table 1: Description of access, purchasing, prescribing, and dispensing pathways of biosimilar mAbs in EU5

blog graphic.png

blog graphic key.png AMNOG: Arzneimittelmarkt-Neuordnungsgesetz (Pharmaceuticals Market Reorganisation Act) 

 KV: Kassenärztliche Vereinigungen (Statutory Health Insurance Physician Associations)

What does the future hold?

It is clear that that the more experienced and mature biosimilar markets (e.g., Germany) tend to have more generic-like pricing and reimbursement policies than the less experienced ones (e.g., US). Over time and as physicians, patients and payers get more experience with biosimilars mAbs they will become increasingly accepted and perceived as generics both by physicians and the legislative environment. Although there are some intrinsic differences between biosimilars and generics (such as in their clinical development and manufacturing processes) that will necessitate the continuing need for separate regulatory processes, the concept of biosimilars having distinct market access nuances will gradually be eroded over time.

DISCLAIMER: This article is for educational purposes only.  Legal or regulatory advice should be obtained for your specific circumstances.

Richard Macaulay and Matthieu Hugon PAREXEL's Pricing & Market Access Group
Ask a Question

Share via

Related Articles

Using Analytics to Optimize The Clinical Development Process

by David Kiger

A recent Bloomberg article discussed how the misuse of web advertising data may have caused companies to waste…

Protocol Optimization

by Sy Pretorius

At PAREXEL, we frequently get asked questions about protocol optimization – what it is, how it works, and trends in…

Ubavka DeNoble Talks About PAREXEL's BioPharm Unit

by Ubavka DeNoble

The BioPharm unit is a business unit that is fully dedicated to collaboration with small to medium size companies. Our…

Topic

BioPharm Business Trends

Biosimilars

Global Drug Development

Market Access

Pricing & Reimbursement

Regulatory and Market Access

Linkedin Updates

View Profile
    Warning: Invalid argument supplied for foreach() in /home/saltwater/www/www.parexel.com/site/themes/parexel-responsive/elements/footer.php on line 27

CAREERS AT PAREXEL®

If you are inspired to make a difference
in the world, we can help you make it possible.

Search job openings worldwide

PAREXEL International Corp.
+1 781 487 9900
195 West Street
Waltham, MA 02451 

  • ABOUT PAREXEL®
  • NEWS & EVENTS
  • VOLUNTEER
  • CONTACT
  • MY PAREXEL PREFERENCE CENTER
  • CLIENT LOGIN
  • LIQUENT®
  • CLINICAL TRIAL INVESTIGATOR
  • SITE MAP
  • TERMS OF SERVICE
  • PRIVACY POLICY
  • EU-U.S. AND SWISS-U.S. PRIVACY SHIELD NOTICE OF CERTIFICATION

Copyright ©2000-2018 PAREXEL International Corporation.