Hospira’s Inflectra, EU’s First Biosimilar mAb, Will Challenge Skeptics
This article was originally published in The Pink Sheet Daily
Hospira’s Inflectra becomes the first biosimilar monoclonal antibody to be authorized in Europe – but pricing and overcoming doctors’ skepticism looks like the key to real EU success.
You may also be interested in...
Pfizer won EU antitrust approval for its plan to buy Hospira after promising to divest certain assets including its own biosimilar version of tumor necrosis factor inhibitor infliximab, to allay competition concerns. Still open are questions about possible buyers and what this means for competitors.
Approval of Sandoz's Zarxio aside, dearth of advisory committee meeting announcements and sponsors' reluctance to discuss status of 351(k) filings suggests regulatory road has not been smooth for some early biosimilar candidates.
"We expect the biosimilar market to behave quite differently" than generics, CEO Alex Gorsky says even as international sales of Remicade fell 20% in the second quarter, though largely due to currency.