Adoption of Biosimilars in Oncology
LOI due Sept. 9, 2020.
The intent of this RFP is to encourage NCCN Member Institutions and non-NCCN Member Institutions tosubmit proposals describing concepts and ideas that develop and validate enduring approaches that improve the safe and efficient adoption of biosimilars in oncology. Proposals that directly measure increases in biosimilar use or improve safety, value and efficiency in oncology practices will be prioritized. The sustainability and broad applicability of the approach will be key factors in evaluating funded projects.
A biological product is biosimilar to a “reference product” based upon data derived from:
1. Analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components;
2. Animal studies (including the assessment of toxicity);
3. A clinical study or studies (including the assessment of immunogenicity and PK or PD) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.