Biosimilar Development solution center

  1. 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.

  2. 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.

  3. Biosimilar Education Strategies for Physicians And Clinicians


    Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

  4. 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.

  5. 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.

  6. How To Adapt Your Existing Biomanufacturing Process To Maximize Production

    Achieving “smarter”, more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

  7. Intensified Chromatography Strategies

    With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact your decisions regarding the implementation of these innovative solutions.

  8. Achieving Operational Efficiency In Today’s Fragmented Market

    Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

  9. 4 Steps Toward End-To-End Connected Manufacturing

    Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

  10. 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.