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 IgE-directed antibody biosimilar (reference product first approved 2002-06-13, Australia).
- Application: IgE-directed antibody biosimilar for immune, respiratory and skin/musculoskeletal diseases, including allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria.
- Purity: Proven high degree of analytical comparability (similarity) to the reference product, supporting regulatory and clinical acceptance as a biosimilar.
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