Biosimilar Regulatory solution center

  1. 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?

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

    In part 1 of this series, we reviewed the relatively slow uptake experienced by biosimilars in the U.S. and speculated on the role pricing and contracting may play. Additionally, we examined how more vigorous uptake has been encouraged by the EU and how some of those policies appear to be migrating to the U.S. Here in part 2, we will highlight 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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?"

  7. 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.

  8. What’s New in U.S. Biosimilar-Land?

    A lot has been promised with the introduction of biosimilars, but can they really deliver a viable alternative treatment to biologics at a substantial savings?

  9. How These Hospital Stakeholders Can Benefit Biosimilar Commercialization

    In Cinfa Biotech’s time preparing for regulatory submission and, hopefully, a future product launch, Jankowsky has noted the increasingly significant role pharmacists play in educating doctors. Much of this comes down to their holistic method of approaching biosimilars — and this was integral in establishing the company’s rationale for development.

  10. What Challenges Should Biosimilar Companies Expect In 2018?

    Whether they be IP-,real-world-data-, or ongoing market-access-related challenges, biosimilar companies should expect a busy year ahead. Biosimilar Development's editorial advisory board members share the challenges they're keeping their eyes on.