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Shilpa Medicare announced that 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.
The Drug had global sales of approximately $19 billion in 2021 and is amongst the most valuable drugs on the market today. The company expects to commercialise the product in the India & RoW markets starting
from the end of the current calender year. SBPL is building a strong biosimilars portfolio around Autoimmune disorders and Opthalmics — via inhouse development and partnerships with global companies.
This biosimilar was fully developed at its integrated Dharwad facility. The company intends to ensure global accessibility to the product via differentiated pricing and formulations/delivery mechanisms.
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