As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.
Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.
Following Peter Bach’s controversial argument to “throw in the towel” on biosimilars, I reached out to three economic experts for their perspectives on how to create a functioning, competitive biologics marketplace and which economic and government policies will be the best to pursue for long-term success.
In this article, a patient advocate from the JDRF shares the diabetes community’s perspective on the upcoming regulatory transition of insulins and how the industry can better engage and educate patients about the future presence of insulin biosimilars.
Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.
Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.
In addition to discussing past challenges, two experts from NeuClone shared insights into the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.
One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.
One technical expert from the WHO outlined the current requirements for the two pathways for biosimilar prequalification and the progresses and pitfalls for companies seeking a spot on the WHO’s list of prequalified medicines.
Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.
|
|
|
|
|
|
|
|
|