Amgen Aims To Add A New Title: Biosimilar Star Player
Executive Summary
Amgen will leverage its strength in biologics as it moves into the burgeoning biosimilar drug market. Its manufacturing capability could provide a leg up versus rivals, and the company showcased its expertise on a recent tour of its Rhode Island biologics manufacturing facility.
You may also be interested in...
Merck’s Revised Biosimilar Strategy Poised To Deliver
The big pharma has five biosimilars in Phase III development with its partner Samsung Bioepis, and expects to file them for regulatory approval in 2015 and 2016.
PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.
RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.