Last week, I had the pleasure of chairing the first day of the BioTech Pharma Summit: Biologics and Biosimilars conference in the gorgeous Porto, Portugal. (Don’t ask me how much I spent on port wine in the days before the conference.) The conference was — shockingly — the first European biosimilar conference I have attended in my tenure as a biosimilars editor. (Even though Europe is leaps and bounds — and then more bounds — ahead of the U.S. with biosimilars.)
A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.
While the biosimilar market in the U.S. has gotten off to a relatively slow start compared to Europe, where biosimilars have been available since 2006, it has recently gained momentum and will continue to grow in the coming years as more “blockbuster” biologics lose regulatory exclusivity and patent protection. Here we review our observations in the biosimilar space since the enactment of the 2009 Biologics Price Competition and Innovation Act (BPCIA) and our view of the future of biosimilars and related patent disputes.
Two employer experts lay out the challenges rebates pose, both for employers and biosimilar uptake, as well as the increasing importance of greater integration amongst employers and health systems from both a biosimilar utilization and an overall cost savings standpoint.
The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress.
In the first of what will be a two-part article, I’ll share two employer organization experts' thoughts on current reimbursement models for biosimilars and how employers and manufacturers can to reshape these practices to bring biosimilars more regularly into employer negotiations.
As policy makers release new policies to reduce healthcare spending, it’s imperative that biosimilar companies emphasize that lowering drug prices and cutting reimbursement are not the same thing. The latter could have serious consequences for critical classes of medicines, including biosimilars.
In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.
Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.
Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.
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