FDA Approves Truxima (rituximab-abbs), the First Biosimilar to Rituxan, for Treatment of CD20-Positive B-Cell Non-Hodgkin’s Lymphoma

United StatesFDAApproval of Astellas Pharma's Treatment for Acute Myeloid LeukemiaLeukemiaThe launch of the original drug Xospata broke the historical record for the number of new drugs approved by the FDA in a year. On the same day, the FDA also broke another, less publicized record. The FDA approved Celltrion’s Truxima (rituximab-abbs) for marketing, either as monotherapy or in combination with chemotherapy, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL). Truxima is the first biosimilar to Rituxan, a blockbuster anticancer drug approved by the FDA. This hasFDAThe number of biosimilars approved this year reached six, breaking last year’s record of five approvals.

Biosimilars are a relatively new class of drugs. Biologics are typically large molecules with high molecular weights and complex structures. They may require production via biotechnology using microorganisms, plant cells, or animal cells. The approval of biosimilars is based on data demonstrating that they areFDAApproved biologics are highly similar, with no clinically meaningful differences in safety, purity, and potency. They must also meet other regulatory requirements.

FDAThe approval of Truxima was based on a review of a totality of evidence, including structural and functional assessments, animal study data, pharmacokinetic data, clinical immunogenicity data, and other clinical data. These data demonstrated that Truxima is highly similar to Rituxan. Truxima was approved as a biosimilar, not as an interchangeable product.

Due to the complexity of biologic manufacturing processes, the FDA has approved only a limited number of biosimilars, with just 18 biosimilar products approved to date. However, since Dr. Scott Gottlieb assumed office as the new FDA Commissioner last year,FDAPrioritizing the development of generic drugs and biosimilars as a key focus, with significantly accelerated approval timelines for biosimilars.

“As part of the FDA’s Biosimilars Action Plan, we have introduced several new policies to make the development of biosimilars more efficient, providing biosimilar developers with greater opportunities to create successful and competitive products. Our goal is to promote competition and expand patients’ access to important medicines,” said Dr. Scott Gottlieb, Commissioner of the FDA. “Truxima is the third biosimilar we have approved in the past month. The growing pipeline of biosimilar candidates is encouraging. We will continue to ensure that biosimilars undergo rapid and effective review and meetFDAapproved stringent standards.”BioValleyBioon.com）