Biosimilar Regulatory solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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?

  5. 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.

  6. How Biosimilar Companies, Employers Can Collaborate, Address Healthcare Challenges

    In addition to understanding what influences employers’ health plan decision-making, it’s important to note employers' growing demands for greater pricing transparency and the complexity posed by the lack of an integrated benefits system.

  7. The U.K. Biosimilar Commissioning Framework: The Path Toward Implementation

    It’s been hard to miss some of the good buzz coming out of the U.K. as the acceptance and adoption of biosimilars continues to be one of the strongest across Europe, and the NHS published its highly anticipated framework to help guide the use of biosimilars. But how the new framework will shape the U.K. biosimilar market is only just being seen.

  8. Views From The U.K.: What Biosimilar Evolutions Are Worth Watching?

    The first of this three-part article touches on the current biosimilar-related developments ongoing in the U.K., as well as what the new chair of the British Biosimilars Association (BBA) is keeping her eyes on, both in the U.K. and globally.

  9. Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

    There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

  10. 2018 CBI Biosimilars Summit Unveils New Industry Focus Areas

    As more real-world evidence demonstrating biosimilars’ efficacy and safety is released, I daresay I speak for many in the U.S. who are left asking, “What more do we need?” Well, this event turned me on to a few areas that could use some work and renewed attention.