• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Solution Center
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Solution Center
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    CDMOs in the Spotlight: Investing in Themselves

    Extrusion-Spheronization in OSD Manufacturing

    Modernizing Therapeutic Cell Production

    Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold

    Digital Transformation in Pharma
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    ValiRx Signs Lease Deal with Nottingham Laboratories

    Civica Partners with Ypsomed for Insulin Injection Pen

    Charles River Laboratories Completes the Acquisition of SAMDI Tech

    Selkirk Pharma Names New Director for Business Development

    Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing

    Upsher-Smith Opens State-of-the-Art Manufacturing Facility

    Elektrofi, Thermo Fisher Enter Strategic Contract Manufacturing Pact

    Societal CDMO Signs More Than $6M in Work Orders During 4Q22

    Genenta Science, AGC Biologics Enter Development and Manufacturing Service Pact
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Upsher-Smith Opens State-of-the-Art Manufacturing Facility

    Beat the Supply Chain Backlog

    HPNE Launches Innovative Single-Use Assembly Service

    CDMO Selection and Tech Transfer – An Insider’s Guide to Injectables Excellence

    Catalent Bolsters Cell and Gene Services
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    ValiRx Signs Lease Deal with Nottingham Laboratories

    Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing

    Genenta Science, AGC Biologics Enter Development and Manufacturing Service Pact

    Baby Steps Toward the 21st Century

    Modernizing Therapeutic Cell Production
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold

    People and Culture Drive Operational Excellence

    Adare Partners with Veeva to Strengthen Quality Operations

    KBI Secures Swissmedic Regulatory Establishment License for Facility in Geneva

    Enhancing Ease of Use, Batch Turnaround, and Process Flexibility
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Lannett CDMO

    LOTTE BIOLOGICS

    Quotient Sciences

    Almac Group

    Syngene International Ltd.
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Lannett CDMO

    LOTTE BIOLOGICS

    Quotient Sciences

    Almac Group

    Syngene International Ltd.
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Microsites
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Expert's Opinion

    Navigating Uncertainty in Biosimilar Drug Development

    Bryan Katz of Syneos Health and Brittany Scott of Addison Whitney share insights from DIA

    Navigating Uncertainty in Biosimilar Drug Development
    Related Content
    • Calyx Expands US Presence in Response to Growing Demand
    • Quanticate Launches Updated Remote Source Data Verification Platform
    • Calyx Opens U.S. HQ Near Research Triangle Park
    • Almac Offers Expedited IRT Solutions for COVID-19 Trials
    • Gene Therapy Trials
    Bryan Katz, Vice President Integrated Solutions, Syneos Health and Brittany Scott, Creative Director, Addison Whitney, a Syneos Health company07.11.18

    Few people question the notion that biosimilar drugs will someday lower the cost of biologic medicines and improve patient access to advanced treatments. However, the transition isn’t exactly on a fast track.

    In the eight years since the Food and Drug Administration (FDA) opened an approval pathway for biosimilars, only 11 such drugs have cleared regulatory review in the U.S., and just three are currently being prescribed to patients. “The market for these products is not advancing as quickly as I hoped,” FDA Commissioner Scott Gottlieb said in a statement on June 21.”[i]

    In the same statement, the FDA announced plans to withdraw existing guidance on how to assess similarity between biosimilars and reference products. The Agency said in the future, it will issue revised guidance that will reflect advances in analytical techniques, taking stock of challenges trial sponsors face when trying to account for potential lot-to-lot variability.[ii] Noting that these follow-on treatments can cost hundreds of millions of dollars to develop, Gottlieb said, “It’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain.”

    In fact, figuring out how to maximize the benefits and cost savings  of biosimilars is no simple task—as speakers explained and discussed in multiple panel discussions last week at the Drug Information Association (DIA) annual meeting in Boston. From an industry perspective, hurdles to overcome include, complexity of development, lack of familiarity with biosimilars among physicians and nurses, ongoing debates about interchangeability, regulatory confusion, and the persistent drain on resources caused by patent litigation.

    DIA Insights

    During DIA panel discussions we chaired or participated in, a number of speakers highlighted risks for biosimilar developers in an environment where production processes and methods are not publicly disclosed. Developing drugs without that critical information reduces the odds that the follow-on product will be “highly similar” to the reference product.

    In elucidating other obstacles on the path, panelists also commented on the reluctance of investigators to participate in biosimilar trials, with some expressing the view that “there’s already a drug available for my patients.” In other words, unless there’s a significant price differential—well beyond the 15 percent we’re currently seeing, on average[iii]—some physicians feel biosimilars are fixing a situation that isn’t broken.

    Despite these and other hurdles to biosimilar adoption, many people in our industry believe the new drugs will eventually find their footing. When that happens, there will be disruptions in the biopharma marketplace, which may present opportunities for trial sponsors who are deploying cutting-edge techniques and practices. We know, for example, that many physicians are uncomfortable prescribing biosimilars for indications that weren’t part of the protocol.  Perhaps this is an opportunity for sponsors to leverage Real World Evidence to strengthen their case—both to physicians and payers.

    Certainly, comparisons with originator products will become easier and more compelling over time. Consider recent developments in Europe, where adoption rates in multiple disease categories are much higher than in the U.S.[iv]  Panels predicted that we will soon see European data on patients who have been switched from an originator product to a biosimilar, and then switched back as the price on the branded product falls.  Such information, published in respected journals, could be useful both to trial sponsors in the U.S. and to Medical Science Liasons (MSLs) engaging with medical teams.  

    Naming Conventions

    The recent attempt by U.S. regulators to clarify issues involving analytical similarity of biosimilars comes on the heels of the FDA’s guidance on nonproprietary naming of these drugs, which also clarifies the utility of the products. That guidance requires developers of biologics and biosimilars to attach randomized four-letter suffixes to all nonproprietary drug names.

    The objective behind the new naming convention is to improve pharmacovigilance and post-marketing safety, making it easier for manufacturers, researchers, regulators and other stakeholders to track each drug throughout the product life cycle—in adverse event reports, patient records, billing statements, and all other settings. This will also help avoid substitution of a biosmilar product that hasn’t been certified as “interchangeable.”[v]  

    What’s Next?

    While the FDA prepares updated guidance, common sense is the best course of action for biosimilar developers to follow as they navigate many of the obstacles discussed in sessions at DIA. For instance, it makes no sense to embark on biosimilar development without a thorough assessment of the competitive landscape, market potential and intellectual property issues. In the same way, best practices in biologic drug development should be applied to biosimilars—whether it’s the need for early and frequent dialogue with regulators or engagement with the Centers for Medicare & Medicaid Services, as well as with private payers.

    It’s important to remember that biosimilars are still new in most clinical settings. And, while “similar,” they are rarely if ever identical to the reference product, owing to production processes that differ at a cellular level. For these and other reasons, a portion of physicians and patients will continue to harbor concerns--especially if biosimilars come to be substituted for originator drugs without the knowledge of prescribing physicians in some circumstances.

    All of this means communications in physician- and patient-centric contexts will grow in importance as more biosimilars come on the market. Education campaigns focused on doctors and nurses will be indispensable to assure that accurate information is transmitted to patients. Doctors—as much as regulators and payers—will be looking for data that present the most complete picture. Biosimilar developers must be prepared to deliver nothing less.


    [i] https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm611409.htm.  See also STAT coverage of the announcement, which includes the tally of 11 biosimilar approvals and three products commercialized, here: https://www.statnews.com/pharmalot/2018/06/21/fda-withdraws-biosimilars-guidance/

    [ii] Ibid

    [iii] https://www.bloomberg.com/news/articles/2017-08-15/what-s-harder-than-making-copycat-biotech-drugs-selling-them

    [iv]See, for example:  http://www.centerforbiosimilars.com/contributor/sonia-oskouei/2017/10/biosimilars-what-can-the-united-states-learn-from-europe

    [v] Although the FDA supports the use of this term, news stories suggest we have yet to see a single biosimilar “certified” in this fashion.  Much has been written on interchangeability, which is why we decided not to dwell on it in this blog post.

     



     

    Bryan Katz, Vice President, Integrated Solutions, Syneos Health

    Bryan is a product development specialist with more than 20 years of experience across the pharma/ life sciences industry. With projects spanning integrated [clinical-commercial] program planning, deal and transformation strategy, Bryan has delivered over $1bn in accretive enterprise value to clients (measured on an EBITDA-multiple basis). Bryan can be reached at bryan.katz@syneoshealth.com.

     


     

    Brittany Scott, Creative Director, Addison Whitney, a Syneos Health Company

    Brittany provides creative vision through innovative verbal and visual solutions. With more than 15 years of experience, she has worked with a wide range of companies, specializing in pharmaceuticals. Brittany can be reached at brittany.scott@syneoshealth.com.

     

     

    Related Searches
    • Biopharma
    • biotech
    • pharmacovigilance
    • fast track
    Suggested For You
    Calyx Expands US Presence in Response to Growing Demand Calyx Expands US Presence in Response to Growing Demand
    Quanticate Launches Updated Remote Source Data Verification Platform Quanticate Launches Updated Remote Source Data Verification Platform
    Calyx Opens U.S. HQ Near Research Triangle Park Calyx Opens U.S. HQ Near Research Triangle Park
    Almac Offers Expedited IRT Solutions for COVID-19 Trials Almac Offers Expedited IRT Solutions for COVID-19 Trials
    Gene Therapy Trials Gene Therapy Trials
    The Future of Clinical Trials Series: Part II The Future of Clinical Trials Series: Part II
    500+ Sites Join Inato’s Industry Marketplace 500+ Sites Join Inato’s Industry Marketplace
    Prestige BioPharma, Alvogen Enter Agreement Prestige BioPharma, Alvogen Enter Agreement
    Prestige BioPharma, Alvogen Enter Agreement Prestige BioPharma, Alvogen Enter Agreement
    Syneos, Elligo Enter Strategic Collaboration Syneos, Elligo Enter Strategic Collaboration
    Umicore API Facility Passes cGMP Audit Umicore API Facility Passes cGMP Audit
    mAbxience, Amneal Enter Biosimilar Tie-up mAbxience, Amneal Enter Biosimilar Tie-up
    Provention Bio, Intravacc Enter Mfg. Tie-up Provention Bio, Intravacc Enter Mfg. Tie-up
    CRO Industry Update: Big Data Drives Drug Development Efforts CRO Industry Update: Big Data Drives Drug Development Efforts
    Financial Report: Syneos Health Financial Report: Syneos Health

    Related Breaking News

    • Breaking News | CRO News | Industry News
      Calyx Expands US Presence in Response to Growing Demand

      Calyx Expands US Presence in Response to Growing Demand

      RTP-based US headquarters established to meet pharmaceutical companies’ and CROs’ increasing needs for e-clinical and regulatory solutions.
      07.22.21

    • Clinical Trials | CRO News | Information Technology | Reader Showcase
      Quanticate Launches Updated Remote Source Data Verification Platform

      Quanticate Launches Updated Remote Source Data Verification Platform

      Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location
      07.19.21

    • Breaking News | Clinical Trials | Industry News | Information Technology
      Calyx Opens U.S. HQ Near Research Triangle Park

      Calyx Opens U.S. HQ Near Research Triangle Park

      RTP-based headquarters established to meet growing needs for eClinical and regulatory services.
      07.19.21


    • Clinical Trials | Information Technology | Reader Showcase
      Almac Offers Expedited IRT Solutions for COVID-19 Trials

      Almac Offers Expedited IRT Solutions for COVID-19 Trials

      Launches the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments
      07.16.21

    • Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
      Gene Therapy Trials

      Gene Therapy Trials

      Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.
      April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21

    Loading, Please Wait..
    Trending
    • Steriline Provides Fill-Finish Solution For Berkshire Sterile Manufacturing
    • Thermo Fisher, Celltrio Partner On Cell Line Automation Platform
    • Bristol Myers Squibb 4Q Results
    • Astellas Announces New President And CEO And Management Structure
    • Bionova Expansion Project To Quadruple GMP Biologics Manufacturing Capacity
    Breaking News
    • ValiRx Signs Lease Deal with Nottingham Laboratories
    • Civica Partners with Ypsomed for Insulin Injection Pen
    • Charles River Laboratories Completes the Acquisition of SAMDI Tech
    • Selkirk Pharma Names New Director for Business Development
    • Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • CDMOs in the Spotlight: Investing in Themselves
    • Extrusion-Spheronization in OSD Manufacturing
    • Modernizing Therapeutic Cell Production
    • Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold
    • Digital Transformation in Pharma
    • Fill-Finish in Cell & Gene Therapy
    • Early-Stage Biotechs: What’s Essential and What’s Not
    • Five Insights to Maximize Customer-Centric Acquisition Growth
    • Challenges in API Technical Transfer
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    ADM Expands Production to Meet Demand for Probiotics
    Wiley’s Finest Debuts Peak DHA Featuring 600 mg of DHA and 300 mg of EPA
    FDA to Allow Qualified CVD Risk Reduction Claim for Cocoa Flavanols in High Flavanol Cocoa Powder
    Coatings World

    Latest Breaking News From Coatings World

    Personnel Changes at BASF
    Dr. Kurt Wood to Deliver Mattiello Memorial Lecture at ACA’s 2023 CoatingsTech Conference
    hubergroup Chemicals to Debut at the European Coatings Show
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Konica Minolta Introduces Mobile X-Ray Systems to Latin America
    NIH MedTech Program Aims to Develop Neurological Treatment Tech
    Formula Plastics Appoints Bill Gerard as President
    Contract Pharma

    Latest Breaking News From Contract Pharma

    ValiRx Signs Lease Deal with Nottingham Laboratories
    Civica Partners with Ypsomed for Insulin Injection Pen
    Charles River Laboratories Completes the Acquisition of SAMDI Tech
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Tree Hut Introduces Body Wash Line
    Zara Introduces Mini Artists—Beauty Products for Kids
    L’Oréal USA Taps Stephanie Kramer as Chief Human Resources Officer
    Happi

    Latest Breaking News From Happi

    FTC Extends Public Comment Period on Potential Updates to Green Guides
    Arm & Hammer Taps Dave & Jenny Marrs, TikTokers for Budget-Centered 'Give It The Hammer' Campaign
    Meaningful Beauty Age-Proof Hair Care System Now Available on Amazon
    Ink World

    Latest Breaking News From Ink World

    Siegwerk, Wildplastic, TU-Hamburg Partner on Deinking
    Brilliant Group and Terra Firm Launch Partnership
    hubergroup Chemicals Debuts at the European Coatings Show
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    The Oldham Group names Doug McClure technical sales rep
    Siegwerk partnership aims to improve plastic waste recyclability
    CELAB-Europe launches new web hub for liner recyclers
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Toray to Expand PPS Production in Korea
    Masque Bar Launches Compostable Sheet Masks
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Jury Convicts Chiropractor, Orthopedic Surgeon in $31M Fraud Scheme
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Technologies Extends Partnership with the NFL
    OE-A at LOPEC – Printed Electronics Up Close
    Monthly Recap: LG OLED, Avery Dennison and JOLED Top This Month’s Stories

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login