Shilpa Biologicals completes Human Clinical Studies of its Adalimumab biosimilar

23 Aug 2022 , 01:34 AM

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 100mgml High Concentration HC Adalimumab biosimilar and has submitted the dossier to the CDSCO for review and grant of marketingmanufacturing 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 formulationsdelivery mechanisms