Articles by Anna Rose Welch

  1. Biosimilar Competition Is Here To Stay In 2020
    12/5/2019

    Following Peter Bach’s controversial argument to “throw in the towel” on biosimilars, I reached out to three economic experts for their perspectives on how to create a functioning, competitive biologics marketplace and which economic and government policies will be the best to pursue for long-term success.

  2. The Biologic, Biosimilar Insulin Transition: The Patient Perspective
    11/29/2019

    In this article, a patient advocate from the JDRF shares the diabetes community’s perspective on the upcoming regulatory transition of insulins and how the industry can better engage and educate patients about the future presence of insulin biosimilars.

  3. Real-World Evidence & Biosimilars: Weighing The Potential Impact
    11/26/2019

    Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

  4. Transition Biologics: FDA, Industry Examine Regulatory Nuances
    11/22/2019

    Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.

  5. Biosimilars: Not Just Big Pharma’s Playground
    11/20/2019

    In addition to discussing past challenges, two experts from NeuClone provided me with a number of the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.   

  6. EMA Update: What Challenges Are Biosimilars Bringing To The Table?
    11/8/2019

    One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

  7. WHO Elaborates Upon Biosimilar Prequalification Progress
    10/31/2019

    One technical expert from the WHO outlined the current requirements for the two pathways for biosimilar prequalification and the progresses and pitfalls for companies seeking a spot on the WHO’s list of prequalified medicines.

  8. Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know
    10/29/2019

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  9. What Incentivized These Oncology Clinics To Embrace Biosimilars?
    10/23/2019

    I reached out to Dr. Jeffrey Patton, the CEO of Tennessee Oncology and president of physician services and board member at OneOncology to better understand the overall decision to implement Amgen's Kanjinti and Mvasi biosimilars, as well as which mechanisms he believes will help improve biosimilar usage in oncology in the months and years ahead.

  10. Regulators Emphasize Patience In Tailored Biosimilar Development
    10/9/2019

    Though analytical comparability has been embraced by regulators for routine manufacturing changes since 1996, there remain what regulators consider to be analytical limitations giving them pause in determining biosimilarity strictly based on analytics and PK.