Subcategory & Sub-subcategory
Specifications
- Expression System: Optimized mammalian cell line supported by a Drug Master File (DMF) filing, delivering consistently high titers for cost-efficient large-scale manufacturing.
- Regulatory Status: Cell line developed for global regulatory readiness (DMF filing) supporting this CD20-directed bispecific antibody biosimilar (reference product first approved 2009-10-26, US, for chronic lymphocytic leukemia).
- Application: CD20-directed antibody biosimilar for neoplasms and immune/nervous system diseases, with chronic lymphocytic leukemia as a representative indication.
- Purity: Proven high degree of analytical comparability (similarity) to the reference product, supporting regulatory and clinical acceptance as a biosimilar.
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