We are delighted to announce that Shilpa Biologicals Private Limited (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited (SML), has received the Marketing Authorization Permission for its Adalimumab 40 mg/0.4mL injection in a prefilled syringe (PFS), a biosimilar of adalimumab higher concentration formulation (100mg/mL) in India. This is used for the treatment of Rheumatoid Arthritis (moderate to severe active RA & severe active and progressive RA) for which the phase 3 clinical trial has been successfully completed in Q3 2022. This formulation will contribute to increased patient comfort based on reduced injection volume.
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