Request for Proposals (RFP)
Biosimilars
Education
in Solid Tumors
Application Due:
October 16, 2019
The goal of this RFP is to support the prudent (safe and effective) use of biosimilar drugs in the treatment of solid tumors, in particular colorectal cancer, and HER2+ breast cancer.
Proposals should aim to increase clinician and patient understanding of complex biosimilar concepts including but not limited to:
- extrapolation of indications (e.g. for biosimilar indicated in colorectal cancer but not clinically studied in colorectal cancer, including scientific and regulatory rationale/points of view);
- the analytical foundation for demonstrating biosimilarity and the regulatory framework governing the approval of biosimilar drugs including explanation of key analytical (structural and functional) evaluations, interpretation of key functional and structural analytical data, and implications for clinical practice