Celltrion Biosimilar Package Strong, But How Many Indications Will It Get?
This article was originally published in PharmAsia News
Executive Summary
Like Zarxio before it, Celltrion’s biosimilar infliximab product Inflectra is coming before a US advisory committee having received a glowing review from FDA staff; but the key question seems to be how many of Remicade's indications will it be able to extrapolate.
You may also be interested in...
As They Look To The U.S., Celltrion And Hospira Win Approval For Remicade Biosimilars In Canada
The first biosimilar MAb approval in Canada could mean Korea’s Celltrion and its partner Hospira are getting closer to filing in the U.S.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.