Guest Columns

  1. The Impact Of Regulatory & Analytics Evolution On The Biopharma Industry

    This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry. 

  2. 6 Ways Biosimilar Companies Should Engage State Governments

    This article provides insights and several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. 

  3. Why Biosimilar Makers Should Pay More Attention To U.S. State Governments

    A critical mechanism in the U.S. constitutional framework is often overlooked in a larger public affairs strategy — the right of a state to govern itself in most aspects. This article conveys the importance of shifting resources from the federal campaign efforts to a more local effort to ensure biosimilar success.

  4. How Should Biosimilar Companies Approach Real-World Evidence?

    Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?

  5. The European Biosimilars Landscape: What To Expect In The Year Ahead

    Europe is set to have another significant year of biosimilar approvals and launches in 2018, following the slew of biosimilar approvals in 2017. Overall, there are now over 40 EC-approved biosimilar products, across 15 different biologic classes.

  6. Indication- And Reference-Based Pricing: A Positive For Biosimilar Manufacturers?

    To address the concept that the price of a treatment reflects its value for the patients being treated, some have recommended a shift from a one-drug, one-pricing approach to an indication- or reference-based pricing approach. 

  7. Partnering With Insurers To Improve Biosimilar Access In The U.S.

    Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.

  8. Unlocking The Potential Of Real-World Data: Tapping Into Today’s Data To Improve Healthcare Tomorrow

    Healthcare is undergoing a shift in how key stakeholders approach and evaluate patient data -- driven by growing access to and general use of real-world data, such as de-identified patient data collected and analyzed from registries, electronic health records, wearable devices, and administrative and healthcare claims databases. This type of data is increasingly being utilized by industry representatives to help inform device development, health system operations, formularies and resulting coverage, and patient care decisions.

  9. Electrospinning & The Future Of Continuous Pharmaceutical Manufacturing

    Blair Brettmann, Ph.D., assistant professor in Georgia Tech’s School of Materials Science and Engineering, discusses the current state of continuous manufacturing in the pharmaceutical industry, her group’s research into electrospinning and other novel approaches, and how to overcome the challenges to further adoption of continuous processes.

  10. How The EU Influences U.S. On Biosimilar Interchangeability & Other Policies

    This articles highlights the meaning of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.