Subcategory & Sub-subcategory
Specifications
- Expression System: Optimized mammalian (CHO) 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 with global regulatory readiness in mind (DMF filing) to streamline submissions for this CD20-directed mAb biosimilar (reference product first approved 2017-03-28, US).
- Application: CD20-directed monoclonal antibody biosimilar for immune-mediated and nervous system diseases, notably relapsing and primary progressive multiple sclerosis.
- Purity: Proven high degree of analytical comparability (similarity) to the reference product, supporting regulatory and clinical acceptance as a biosimilar.
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