• Biosimilar News You May Have Missed During COVID-19

    There have been a few exciting pieces of news and industry movements that are worth noting as we approach fall. In general, I anticipate these topics will continue to come up and/or shape biosimilar conversations in the years ahead. 

  • Sandoz: Critical Initiatives For The New Canadian “Biosimilars Generation”

    Following the launch of The Biosimilars Generation, I sat down with Sandoz's Karine Matteau. In addition to sharing the goals of the educational initiative, she also discussed how biosimilar companies and governments can encourage greater biosimilar buy-in among all stakeholders.

  • Expectations Vs. Reality: The Financial Impact Of Market Delays On Biosimilars

    Given originators' actions and the resulting commercialization risks, as well as the inherent technical risks of biosimilar drug development, how can one possibly expect a biosimilar to launch at a 90 percent discount to the brand? Let’s create a hypothetical example that closely mimics the reality biosimilar manufacturers are facing today and discuss how that impacts the discounts they can provide.

  • A Novel CAR-T Cell Therapy Approach Using Fluorescence-Activated Cell Sorting And Stem Cell Transplantation

    Successful chimeric antigen receptor- (CAR-) T cell therapy requires a target antigen that is unique to cancer cells. But what happens when there are no unique antigens? Researchers at Columbia University Medical Center addressed this problem by replacing healthy non-target cells with genetically modified versions lacking the CAR-T cell target (Borot et al., 2019). Their results, published in PNAS, may provide a new avenue for treatment of some types of cancer.

  • A New International Standard To Measure DNA?

    The breadth of digital PCR (dPCR) applications continues to grow and fulfill critical scientific needs. One of the major advantages the technology confers is the ability to count nucleic acid molecules directly, rather than extrapolating quantity based on standard curves as with many other methods. By harmonizing diagnostic procedures on dPCR platforms, the scientific and medical communities can become more coordinated and efficient than ever before.

  • 10 Tips For Setting Up A Successful Cell Sorting Experiment

    Presented here are some tips to keep in mind when starting a cell sorting experiment. They will help you to maximize cell viability, separation, and isolation, and set you up for successful downstream applications.

  • Sorting An Old Problem: Are Cells Stressed By Fluorescence-Activated Cell Sorting?

    Fluorescence-activated cell sorting is a valuable tool for research, allowing separation of a mixture of cells into distinct populations for analysis. But could the physical forces of sorting stress the cells, altering their behavior and confounding experimental results? Andrä et al. (2020) found that although cell sorting activated p38 MAPK stress signaling, no functional or structural changes were observable. The results indicate that jet-in-air systems such as the Bio‑Rad S3e Cell Sorter do not alter cell behavior.

  • 7 Tips For Purchasing Your Next Cell Sorter

    This article shares some tips to help you avoid buyer’s remorse and make an educated decision about which instrument to purchase. These tips provide you with the tools to make an informed decision when purchasing a cell sorter.

  • Meeting The Process Development Challenges Of A Diverse Biologic Pipeline

    The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  

  • Strategies For Intensifying Your Biomanufacturing Processes

    An increase in therapies targeting smaller niche segments of the market rather than blockbuster drugs for large patient populations is creating new pressures on biomanufacturers to meet patient needs. As a result, there is a growing focus on implementing process intensification approaches as a way to produce high-quality drugs in a more efficient and cost-effective way. Cytiva has compiled this ebook about solutions and strategies you can consider during your own journey toward a faster and more flexible, cost-effective approach to drug development and manufacturing.

  • Celltrion: Shaking Up Biosimilars One Bioinnovative At A Time

    In this Q&A, HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcare, shares the biggest market-related considerations and regulatory challenges facing a biosimilar company exploring both biosimilars and bioinnovative products.

  • Sandoz President: Managing The Biologics, Biosimilars Supply Chain Through COVID-19

    In this Q&A, Carol Lynch, President, U.S. and Head North America for Sandoz, discusses the supply challenges she’s observed in the biologics space throughout the current pandemic and the efforts biosimilar makers should be taking to meet patients’ needs and prepare for future supply disruptions.

  • An Update On 2020 U.S. Biosimilars Regulation & Litigation

    The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

  • Telling Your Biosimilar’s Story: What Data Are Necessary?

    We are at an interesting time in this industry as it relates to biosimilar competition and education. The EU and U.S. are now learning together how to encourage uptake of the curative oncology biosimilars. This raises two questions around what types of data have and will play crucial future roles for improving confidence in your biosimilar.

  • Towards A Better Process Outcome

    In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

  • 3 Healthcare Changes Biosimilar Companies Must Prepare For

    There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

  • Biosimilars In Rheumatology: How To Move The Needle On Uptake, Access

    In this Q&A, one rheumatologist talks through some of the biggest takeaways he had from a recent Cardinal Health survey and how rheumatologists, manufacturers, and payers can better move the biosimilar industry forward for patients.

  • Biosimilars, Oral Biologics, & Continuous Processing: One Virtual Biotech’s Strategy

    The (re)emergence of small biotechs in the biosimilar world has caught my eye in the last year. I sat down (virtually) with the CEO of one such company, BiosanaPharma, to discuss the advantages and challenges of being a virtual biotech pursuing biosimilar and novel biologic development.

  • Africa’s Biosimilar Landscape: Outlook & Current Challenges

    Emerging markets, particularly Africa, represent an interesting case study for biosimilars. With a young population of more than 1.3 billion, Africa’s economy is the world's second-fastest growing, and the GDP is expected to grow to 3.9 percent in 2020 and 4.1 percent in 2021, according to the African Development Bank.

  • “Show Me The Data:” New Publication Moves Long-Held Regulatory Debate Forward

    A new peer-reviewed paper, armed with the necessary data, aims to carry us into the days of more tailored biosimilar development. Lead author Martin Schiestl discusses the paper’s most important findings and what implications these data will have for biosimilar developers and regulators.

  • Biosimilar Clinical Trials: Past, Present, And (Near) Future

    As we continue discussing the role of large comparative efficacy studies in the biosimilar development paradigm, two Covance experts focus more specifically on the near-term clinical challenges companies are likely to face as the biosimilar pipeline diversifies in the next few years.

  • Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?

    This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

  • Samsung Bioepis CEO: A COVID-19 Call To Action

    There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

  • The Pharmacist’s Role In Biosimilar Uptake: The Art Of Formulary Management

    Unless we’re pharmacists ourselves, we rarely get a look into the formulary-building process and what this can mean for biosimilar usage overall. Here, pharmacist Sophia Humphreys of Providence St. Joseph Health shares the ins-and-outs of formulary building and the role pharmacists can play to encourage greater biosimilar usage. 

  • Crowded Biosimilar Clinical Trial Landscape Requires Differentiation

    At the U.S. World Biosimilar Congress, Covance's Joan Meyer highlighted the biggest clinical trial challenges and shared tips on how biosimilar companies can communicate the benefits of comparative efficacy trials for patients and investigators alike.

  • Approaches To Improve Efficiency In Biopharmaceutical Process Development

    Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.

  • Is Not Using A CDMO Slowing Down Your Process Development?

    Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

  • Insulin Under The BPCIA: Opportunities And Obstacles

    As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.

  • Biosimilar Interchangeability: 3 Questions That Need Answers

    Though debate on this topic has been simmering on and off for the past few years, members of the biosimilar industry were approaching the nuances of interchangeability with increased zeal at the U.S. World Biosimilar Congress. Here, one expert tackles the lingering questions surrounding interchangeability and its impact on stakeholders.

  • Do We Need Comparative Clinical Efficacy Testing For Biosimilars?

    This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.