Shilpa Medicare via its wholly owned subsidiary, Shilpa Biologicals (SBPL), has successfully completed the phase 3 Human Clinical studies of its first biosimilar, the 100mg/ml High Concentration (HC) Adalimumab biosimilar and has submitted the dossier to the CDSCO for review and grant of marketing/manufacturing license - a first in India.
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets - diseases where India has the largest patient populations.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.