Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.

Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.