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Through a series of strictly regulated preclinical, clinical, and safety studies, A biosimilar medicinal product must compare to the authorized biological drug in terms of physicochemical, nonclinical, and clinical efficacy (known as the reference medicinal product, RMP [EU] or reference product, RP [US]) [12, 13] Advixa is a recombinant human IgG1 mAb that is directed against human TNF- and is developed by Incepta Pharmaceuticals Ltd, Bangladesh

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