The company said that it has submitted the dossier to the Central Drugs Standard Control Organisation (CDSCO) for review and grant of marketing/manufacturing license.

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 durg maker stated.

Shilpa Medicare said that 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 & rest of the world (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, it added.

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.

The pharmaceutical company said that it views Biologics as a strategic growth area and has made significant investments in setting up a high end, flexible biologics facility in SBPL, Dharwad to cater to the requirements of the fast-growing biologics field, that include the DNA vaccine, adenoviral, subunit vaccines, Monoclonal antibodies & fusion proteins.

Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.

The company's consolidated net profit tumbled 46.5% to Rs 0.85 crore on 10% increase in net sales to Rs 261.16 crore in Q1 FY23 over Q1 FY22.