The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Epoetin, Biosimilars, Interchangeable, Substitution, Guidelines

Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy. Biosimilar epoetin was approved by the FDA in 2018 after previous non-approval letters in 2015 and 2017 despite positive reviews by the FDA's Oncologic Drugs Advisory Committee …

Mar 12^th • 7 mins read

Oncology biosimilars: New developments and future directions

biologics in cancer treatment, biosimilars development, high cost of biologics, healthcare system burden, biosimilars safety, regulatory guidelines for biosimilars, immunogenicity concerns, pharmacoeconomics of biosimilars

Biologics are essential in cancer treatment as both therapeutic and supportive care agents, but they are expensive and require extensive testing to ensure safety. The high cost of developing and manufacturing biologics can be a burden on healthcare systems, limiting patient access to necessary tr…

Nov 25^th • 30 mins read

Evaluating External Validity of Oncology Biosimilar Safety Studies

biologics, external validity, FDA, biosimilars, trastuzumab

Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…

Apr 6^th • 2 mins read