Editorial

  1. How Can Biosimilars Make Headway In The U.S. Market?
    6/26/2019

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  2. Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing
    6/21/2019

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.

  3. USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    6/19/2019

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  4. Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know
    6/17/2019

    Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

  5. Are Biopharma's Strong Pipeline Innovations Reaching Patients?
    6/13/2019

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

  6. FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    6/12/2019

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

  7. Trends In Single-Use System Adoption In The Biopharma Industry
    6/10/2019

    Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.

  8. Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance
    6/5/2019

    Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

  9. Can The FTC Clear A Path For Biosimilar Access Through The Patent Thicket?
    6/4/2019

    The existence of what we now call “patent thickets” is a threat to the biosimilar industry (as well as to the introduction of affordable generic drugs). The possibility that innovator medications like AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept) can retain market exclusivity decades beyond their original date of introduction angers all except the manufacturers’ shareholders.

  10. Is Continuous Manufacturing Right For Your Drug?
    5/30/2019

    Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.