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.
In this article, Dr. Edgerton walks me through AHG’s considerations and efforts in gaining payer buy-in on this value-based pathway, as well as how this initiative has given rise to a new, rheumatology-centric group purchasing organization (GPO) known as the Articularis Rheumatology Network (ARN) GPO.
In the first of what will be two articles, I’ll share how one large rheumatology practice, AHG, established a value-based pathway that increased its providers' reliance on infliximab biosimilars.
In light of all the noise surrounding this Act, I reached out to reimbursement policy guru and Biosimilar Development editorial board member extraordinaire, Molly Burich. Here, she shares her initial thoughts on how several proposed changes to alter reimbursement under Medicare Part B and D could play out in the biosimilar space should the bill be made law.
In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.
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