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.
I reached out to Dr. Jeffrey Patton, the CEO of Tennessee Oncology and president of physician services and board member at OneOncology to better understand the overall decision to implement Amgen's Kanjinti and Mvasi biosimilars, as well as which mechanisms he believes will help improve biosimilar usage in oncology in the months and years ahead.
Though analytical comparability has been embraced by regulators for routine manufacturing changes since 1996, there remain what regulators consider to be analytical limitations giving them pause in determining biosimilarity strictly based on analytics and PK.
While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.
Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?
Prior to the DIA Biosimilars Conference, I wanted to catch up with speaker Julie Reed of Pfizer to see what she’s most excited about imparting to attendees and what she hopes to learn from the upcoming conference.
I reached out to learn the inflammatory arthritis patient community’s thoughts on BC's large-scale transition to biosimilars. I also wanted to know which best practices the government employed behind-the-scenes to ensure the policy would be a success.
Though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.
