Why Interchangeability Won’t Be The “Silver Bullet” For Biosimilar Uptake
Why Interchangeability Won’t Be The “Silver Bullet” For Biosimilar Uptake

We’ve continued to see more data released emphasizing the safety of biosimilar switching abroad. However, as Merck KGaA Darmstadt Germany's Sue Naeyaert argues, these data alone are unlikely to be the silver bullet to greater biosimilar uptake. In an interview, Naeyaert shared her thoughts about how interchangeability in the U.S. will play out, as well as how biosimilar use could be incentivized in the fragmented American healthcare system.

  • What Biosimilar Companies Should Think About A 70 % Discount
    What Biosimilar Companies Should Think About A 70 % Discount

    Edric Engert, managing director of Abraxeolus Consulting (formerly of Teva), shares his opinions on where the biosimilar market is heading, how we can promote greater uptake within the U.S., and just how “genericized” the market can and will potentially become.  

  • Biosimilars: Differentiating And Surviving The Cost Of Entry
    Biosimilars: Differentiating And Surviving The Cost Of Entry

    This is the third article in a series on biosimilars. The first two pieces layout the background of the biosimilar market to date and the challenges shaping the market. This article sets out to explain how biosimilar companies are achieving differentiation and what it will take to establish market share.

  • Brexit & The Biopharma Industry: What Happens Next?
    Brexit & The Biopharma Industry: What Happens Next?

    Last year, after the fateful June 2016 Brexit referendum that ended in a shocking win for the “Leave” camp, I wrote an article discussing the options going forward and the uncertainty that faced the biopharmaceutical industry. Now, almost a year later and after the official triggering of Article 50 — through a letter delivered by Eurostar, no less — have we actually learned anything new?

  • Samsung Bioepis: Turning “Lessons Learned” Into Biosimilars
    Samsung Bioepis: Turning “Lessons Learned” Into Biosimilars

    In the pharmaceutical industry, five years is a short length of time in which to launch a company, establish a development process, and bring several biosimilar candidates to market. In an interview, Paul Song shared some of the efforts Samsung Bioepis has made to pass down lessons learned and to continue evolving in the years ahead.

  •  Trump’s Deregulatory Agenda:  What It Could Mean For Biopharma & Medtech Companies
    Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

  • The Players In The Biosimilar Market
    The Players In The Biosimilar Market

    This article provides details of the different players that exist in the complex biosimilar market, all of which have different characteristics, histories, reasons for entry, internal capabilities and resources available to support their programs.

  • Pharmacy Benefit Managers: Fixing Healthcare Market Failures Or Straining Regulatory Control?
    Pharmacy Benefit Managers: Fixing Healthcare Market Failures Or Straining Regulatory Control?

    Given the contradictory atmosphere surrounding PBMs, how is one to know whether structural relief is needed or, on the contrary, if overregulation should be averted?

  • Biosimilars: What’s Happened So Far?
    Biosimilars: What’s Happened So Far?

    Based on a detailed review of the biosimilar market, it is clear that  this market is highly dynamic. While the biosimilar market has not yet fully lived up to the initial expectations, it may be on the brink of considerable and rapid change.

  • Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

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BIOSIMILAR INSIGHTS

  • Evolve With Flexibility: Advancing Single-Use Technology With Industry Collaboration

    GE Healthcare has compiled this ebook, which includes information on some of the latest SUT trends in the world of bioprocessing.

  • Capitalize On Your Merger/Acquisition: 4 Tips To Consolidate Your CMO Network

    New drugs acquired via mergers, acquisitions or licensing agreements often come with an entourage of contract manufacturers. After several such transactions, you can find yourself surrounded by a tangle of CMOs. That’s problematic. Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting. Where do you begin?

  • Beyond Immune Checkpoint Inhibitors To A New Era Of Personalized Medicine

    Immunotherapies are being touted—both in scientific literature and the general media—as the most promising advances in cancer treatment in decades.

  • A DoE Approach To Liquid-Liquid Mixing

    This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM/ XDUO 500 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a statistical model to predict the mixing time throughout the working range.

  • DoE Approach To A Model Predicting Liquid-Liquid Mixing Times

    This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM/ XDUO 200 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range. Liquid-liquid mixing times as low as 13 s were observed at the nominal volume (200 L) and highest viscosity tested (20 cP).

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TRAINING COURSES

Understanding and Implementing the New EU Regulation for Initiating and Conducting Clinical Trials May 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Bioprocess Facility Design - Layout Rules and Configurations May 10, 2017
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Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for Success May 11, 2017
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Cloud Computing In A GxP Environment: Three Key Success Factors May 16, 2017
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Manufacturing & Laboratory Equipment Qualification – Ensuring Bullet-Proof Results May 17, 2017
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Drug Development 101 – How A Drug Is Made May 18, 2017
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EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement May 23, 2017
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Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
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ACI’s 8th Annual Summit on Biosimilars June 12 - 14, 2017
New York, NY
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm EDT, Online Training
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 EVENTS

Understanding and Implementing the New EU Regulation for Initiating and Conducting Clinical Trials May 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Bioprocess Facility Design - Layout Rules and Configurations May 10, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for Success May 11, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cloud Computing In A GxP Environment: Three Key Success Factors May 16, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Manufacturing & Laboratory Equipment Qualification – Ensuring Bullet-Proof Results May 17, 2017
1pm-2pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!

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