Stelis Biopharma receives major success for its first biosimilar product Kauliv

18 Nov 2022 , 01:34 AM

Stelis Biopharma the biologics arm of Strides Pharma Science announced that its product division Biolexis has a major success with its first biosimilar product Kauliv receiving a positive recommendation from European Medicines Agency EMA for granting of market authorization

Kauliv is a recombinant human teriparatide injection intended for the treatment of osteoporosis

The Company informed that EMAs Committee for Medicinal Products for Human Use CHMP had adopted a positive opinion recommending granting marketing authorization for Kauliv on 11 November 2022

Kauliv is a biosimilar to Forsteo innovator product indicated for both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures The product is developed on a recombinant Escherichia coli host platform similar to the innovator Kauliv provides reusable and disposable pen device options to cater to the global market demand

Forsteo innovator product is currently the market leader among the treatment options of bisphosphonates and Selective Estrogen Receptor Modulators SERMs and remains a gold standard drug for the treatment of osteoporosis with >$800 million global sales in a total market size of >$15 billion

Kauliv will be available as a 20 g80l solution for injection For the European markets Kauliv will utilize a CE marked reusable pen device developed based on the clinically proven Autopen platform by Owen Mumford Limited a United Kingdom-based medical device design and manufacture company

Stelis will manufacture this product at its USFDA and EU authority-approved facilities in Bangalore India and will scale the opportunity globally through a B2B model The Company has already licensed Kauliv across 20 countries and the commercialization of the product will generate incremental revenues for Company starting FY24 after country-specific registrations are completed