Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.
Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.
While we’ve certainly seen progress on the march towards true global development, there’s still a way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.
ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.
During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.
In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.
Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.
I particularly enjoyed a conversation amongst a panel of physicians at a recent conference, several of whom elaborated upon the value increased use of biosimilars can bring to the table — both for patients and physicians. And though savings and access are main goals, physicians also see another critical benefit of greater biosimilar use.
Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.
Overall, four talking points arose during the presentations that I felt were worthy of briefly singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.