Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years

Innovation, Expanded access, Early drug access, Cancer, FDA, EMA

Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…

Apr 7^th • 12 mins read

Uptake of Oncology Biosimilars: Managed Care Strategies to Improve Value-Based Care Systems

biosimilars in oncology, cost-effective cancer care, healthcare education, bioequivalence studies, biosimilar adoption, cancer treatment protocols

Biosimilars offer a cost-effective alternative in oncology, expanding access to cancer care, but their utilization is inconsistent due to varying perceptions and knowledge among stakeholders. Increasing the adoption of biosimilars requires improved education and understanding among healthcare pro…

Jul 7^th • 25 mins read

Outcome measures for oncology alternative payment models: practical considerations and recommendations

Oncology, payment, models

This paper focuses on synthesizing existing research on quality measures in oncology, particularly outcome-based quality measures which are underutilized. A set of "core outcome measures" is proposed for future oncology alternative payment models (APM). The study design includes a literature rev…

Dec 1^st • 10 mins read

Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology

bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach

Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…

Jun 24^th • 18 mins read

Addressing oncologists' gaps in the use of biosimilar products

biosimilar products, FDA, biosimilars, COA

The study highlights significant gaps in knowledge, competence, and confidence among oncologists regarding biosimilars. Educational interventions notably improved clinicians' understanding of the biosimilar approval process and familiarity with approved products. Post-education familiarity with the …

Jun 19^th • 5 mins read