Big Pharma May Be Big Player in Follow-On Biologics Market
This article was originally published in RPM Report
Executive Summary
As Congress works on an approval pathway for follow-on biologics, generic drug companies are jockeying for investors' attention. But given that most generic manufacturers may be ill-equipped to handle the development of follow-on proteins, some analysts think the real opportunity is where you'd least expect: inside Big Pharma and biotech.
You may also be interested in...
Believing In Biosimilars: Industry Takes Long View on FDA Pathway
FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.
Believing In Biosimilars: Industry Takes Long View on FDA Pathway
FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.
FDA's Balancing Act: Early Hints at a Biosimilars
FDA opened the regulatory phase of the biosimilar debate by hearing from industry and other stakeholders about what an approval system should look like. But this information-gathering session wasn’t all one-sided: FDA officials offered some hints of what they are thinking too. And while there are some significant areas of disagreement—and outlier positions—there was also quite a bit of common ground.