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?

• The Importance Of Humanizing Biosimilars
• Pfizer Executives Elaborate On Payer Biosimilar Contracting Goals, Challenges
• Stakeholders To Gather In London To Plan Biosimilar Market’s Future

• 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. Biosimilars of trastuzumab, adalimumab, and pegfilgrastim are soon to become additions to the European biosimilars armamentarium, with the potential to rapidly capture notable market shares owing to the cost savings they will offer European healthcare systems

• 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. 

• 3 Biosimilar Barriers In Community Clinics

  In the first of this two-part article, McKesson experts share insights on two biosimilar barriers they’ve noticed in community clinics and highlight their takeaways from infliximab’s and filgrastim’s experiences tackling these barriers.

• 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.

• 90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?

  This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.

• 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.

• 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.

• Does The U.S. Biosimilar Space Have A Case Of “Progressophobia?”

  A prediction that a failure of the U.S. biosimilars market could lead to the end of the global biosimilars market begs the question of how we evaluate progress, as well as how such a prediction could be avoided.

• Could This Practice Increase Biosimilar Use In The U.S.?

  What could a country like the U.S. and big payers like the Aetna’s, UnitedHealthcare’s, or even the PBMs like CVS learn from what other countries have done to garner savings for their healthcare systems and potentially reduce costs for patients?

BIOSIMILAR INSIGHTS

• Preparing For The Future - Visions And Insights For Biomanufacturing

  In this e-book, you’ll find insight and advice from some of the industry’s top experts about current trends in biomanufacturing, modern process intensification techniques and the outlook for digital automation.  We’ll explore innovative process approaches that can be applied at various scales and stages of development in hopes of providing you with a visionary guide of how to effectively manufacture your molecule.

• Nunc Roller Bottles Excel With ST, Vero, And MDBK Cells Application Note

  A third-party study was conducted to compare the performance of Thermo Scientific™ Nunc™ Roller Bottles (1.2 and 2.5X) and 850 cm² roller bottles from another supplier, for the culturing of ST, Vero, and MDBK cells.

• Rapid, Serum-Free, High-Yield Antibody Production In Nunc PETG Roller Bottles Application Note

  A rapid, flexible, and high-yield approach both hybridoma expansion and for antibody production using a serum-free medium in Nunc PETG Roller Bottles.

• Nunc Cell Factory System Extractable Review

  How product design influences biopharmaceutical manufacturer extractable profiles.

• Master Cell Bank Production Of Liver Carcinoma Cells

  Improved productivity using a Nunc High Density Cell Factory 52-layer system.