Editorial

  1. Is It Time To Throw In The Towel On Biosimilars In The U.S.?
    8/23/2019

    Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

  2. A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers
    8/21/2019

    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.  

  3. 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    8/20/2019

    Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.

  4. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    8/14/2019

    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. 4 (More) Critical Considerations For Drug Delivery Device Development
    8/12/2019

    Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  6. Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    8/8/2019

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  7. Breast Cancer Patient Organization Sets Sights On Biosimilars
    8/7/2019

    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.

  8. 4 Important Things To Consider Before Developing A Drug Delivery Device
    8/6/2019

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  9. What Can Cell & Gene Efforts Teach Biosimilar Makers?
    8/1/2019

    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.

  10. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    7/31/2019

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.