Shilpa Biologicals gets marketing authorization permission for Adalimumab 40 mg/0.4mL injection in prefilled syringe in India

Karnataka: 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 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.

Rheumatoid arthritis is a chronic disease that causes inflammation around the body and commonly presents with pain in the joints.

"This formulation will contribute to increased patient comfort based on reduced injection volume," the Company stated in a BSE filing.

"Shilpa Biologicals' extensive research and development efforts have resulted in the successful development of a high concentration biosimilar that matches the safety, purity, and potency profiles of the reference product," the Company further stated.

SBPL has been working on development of biosimilars catering to different therapeutic areas such as Immunology, Oncology, Ophthalmology, among which, Adalimumab is the first Biosimilar from Shilpa Biologicals Private Limited.

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The product will be manufactured and supplied from the company's state-of-the-art biologics manufacturing unit located in Dharwad, Karnataka.

Medical Dialogues team had earlier reported that Shilpa Medicare had received final approval from the U.S Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg.

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