Believing In Biosimilars: Industry Takes Long View on FDA Pathway
This article was originally published in RPM Report
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.
You may also be interested in...
Beyond ObamaCare: Big Pharma, Health Reform and the 2012 Elections
Most everyone can agree that health care costs are spiraling out of control. President Obama and his Republican challenger Mitt Romney each say they have a plan to cut spending. But while those are being debated, a high-profile group of former Obama advisers are suggesting something much more radical: a systematic change in the way we pay for health care. Could it be a blueprint for a second Obama term?
Biosimilarity vs. “Cognitive Dissonance”: The Ongoing Challenges to New FDA Pathway
FDA is still awaiting its first biosimilar product application – and there is no reason to expect a flood of products any time soon. The new pathway faces legal, logistical and resource obstacles. But the most important barrier may be the need for a mindset change.
Is Merck Less Bullish on Biosimilars?
Of all the Big Pharma manufacturers, none seemed more optimistic about the commercial potential of biosimilars than Merck. But over the last several months, Merck shut down its BioVentures Group and skipped an FDA public meeting on the abbreviated approval pathway. Has Merck soured on biosimilars?