Biosimilar Regulatory solution center

  1. Biosimilars Pipeline Shows Remarkable, Sustained Growth
    3/7/2019

    The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress. 

  2. One Issue Tailor-Made For Biosimilar Maker-Employer Collaboration
    3/6/2019

    In the first of what will be a two-part article, I’ll share two employer organization experts' thoughts on current reimbursement models for biosimilars and how employers and manufacturers can to reshape these practices to bring biosimilars more regularly into employer negotiations.      

  3. Recent Reimbursement Policies Aim To Shake Up Biologics Buy-And-Bill
    2/28/2019

    As policy makers release new policies to reduce healthcare spending, it’s imperative that biosimilar companies emphasize that lowering drug prices and cutting reimbursement are not the same thing. The latter could have serious consequences for critical classes of medicines, including biosimilars.   

  4. Two Biosimilar Policies Raise Questions About Reimbursement Consistency
    2/25/2019

    In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

  5. Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In
    2/19/2019

    Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.

  6. Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    2/11/2019

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

  7. What Is Skinny Labeling — And Will It Work For Biosimilars?
    2/5/2019

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

  8. 2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach
    1/31/2019

    Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.

  9. The Evolving Landscape Of Medical Science Liaisons
    1/24/2019

    Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.

  10. How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    1/24/2019

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.