Biosimilar Sponsors Offer Advisory Committee Primer
Executive Summary
Extrapolation, uncertainty could prove important when the Oncologic Drugs Advisory Committee considers Sandoz’s filgrastim biosimilar on Jan. 7.
You may also be interested in...
Lessons From The First Biosimilar MAb Launch In Europe
Physicians appear more willing to prescribe Hospira’s Inflectra, a biosimilar version of J&J’s Remicade, to new patients in countries in Europe where it is available, but less inclined to switch patients already taking the brand. The company’s experience in Europe could offer lessons for manufacturers looking to bring biosimilars to market in the US.
Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway
Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.