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Updated Biosimilars Statement Anticipates Future Approvals
The NCCN guidance transitioned from a specific focus on rituximab to a broad, future-proof policy covering all FDA-approved biosimilars, which simplifies treatment decisions and promotes patient access.
EP: 1.The Clinical Utility of Updated Immunophenotyping Guidelines in Follicular Lymphoma
EP: 2.Challenges to NGS Testing for Follicular Lymphoma in the Community Setting
EP: 3.Data Supporting Tafasitamab, Lenalidomide, and Rituximab in Second-Line Follicular Lymphoma
EP: 4.Considering Third-Line Loncastuximab Tesirine Plus Rituximab in Follicular Lymphoma
EP: 5.Sequencing Anti-CD19 Therapies in Follicular Lymphoma
EP: 6.Patient Factors Influencing Follicular Lymphoma Treatment Sequencing
EP: 7.Updated Biosimilars Statement Anticipates Future Approvals
EP: 8.Using Prior Response and Repeat Biopsy to Guide Sequencing Strategy in Follicular Lymphoma
The National Comprehensive Cancer Network (NCCN) Guidelines statement on biosimilars was revised to include any appropriate biosimilar for a therapy vs focusing on rituximab. The revision was designed to make the guidance more generic and broadly applicable across oncology disciplines. A narrow scope was practical at the time the initial statement was included, as rituximab was the only relevant biosimilar within the specific B-cell malignancy guidelines being referenced. The original rule affirmed that the substitution of a rituximab biosimilar for the reference product (Rituxan) was appropriate when an anti-CD20 antibody was called for.
However, the policy was updated in anticipation of a rapidly growing landscape of approved biosimilars. The goal was to establish a single, comprehensive standard that could cover all clinical guidelines without requiring repetitive, drug-specific updates. This move allows the statement to immediately encompass biosimilars for agents outside of hematology, such as trastuzumab (Herceptin) in breast cancer.
The new, universal statement simplifies decision-making for clinicians: If an FDA-approved biosimilar is available, its substitution for the original product is appropriate across all NCCN guidelines. This change did not affect the original clinical stance regarding rituximab but shifted from a product-specific endorsement to a blanket policy. This standardization is key for maximizing patient access to effective treatments while maintaining high quality of care.
