Stelis Biopharma Limited, the biologics arm of Strides Pharma Science Limited, 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 EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion, recommending granting marketing authorization for Kauliv on November 11, 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 pen2 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 >$1.5 billion.

Kauliv will be available as a 20 μg/80 μl solution for injection. At the molecular level, teriparatide binds to the human parathyroid hormone receptor with a similar affinity as the human parathyroid hormone and effect a similar molecular signaling mechanism to act on bone metabolism.

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.