Anna Rose Welch articles

  1. How One Rheumatology Practice Bolstered Uptake Of Biosimilar Infliximab

    In this article, Dr. Edgerton walks me through AHG’s considerations and efforts in gaining payer buy-in on this value-based pathway, as well as how this initiative has given rise to a new, rheumatology-centric group purchasing organization (GPO) known as the Articularis Rheumatology Network (ARN) GPO.

  2. Why This Biosimilar Initiative In Rheumatology Is One To Watch

    In the first of what will be two articles, I’ll share how one large rheumatology practice, AHG, established a value-based pathway that increased its providers' reliance on infliximab biosimilars.   

  3. A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers

    In light of all the noise surrounding this Act, I reached out to reimbursement policy guru and Biosimilar Development editorial board member extraordinaire, Molly Burich. Here, she shares her initial thoughts on how several proposed changes to alter reimbursement under Medicare Part B and D could play out in the biosimilar space should the bill be made law.  

  4. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  5. Breast Cancer Patient Organization Sets Sights On Biosimilars

    During our discussion, I learned more about this patient organization and its biosimilar education goals, as well as what type of information could be particularly helpful for the breast cancer patient community at this point in time.

  6. What Can Cell & Gene Efforts Teach Biosimilar Makers?

    Not only are the issues impacting cell and gene therapies relatable on the biosimilar side, I’m hoping this particular strategy can inspire creative thinking as scrutiny into the buy-and-bill landscape continues to intensify.

  7. Cutting Through The Noise: The Bright Side Of Biosimilar Progress

    Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

  8. FDA, USP Debate Standards: How Could This Impact Biosimilars?

    Even though the FDA has argued quite passionately against the need for biologics standards, there are several reasons why I hesitate to embrace their arguments that having these standards in place (and requiring they be met) could be harmful to biosimilars.

  9. Employer Roundtable Highlights Biosimilar Knowledge Gap

    Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

  10. The Debate On Standards In Biologics Development Heats Up

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.