The drug maker said its biologics arm received a positive recommendation from European Medicines Agency (EMA) granting market authorization for Kauliv.
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. EMA's Committee for Medicinal Products for Human Use (CHMP) 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.
Kauliv will be available as a 20 μg/80 μl solution for injection. 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.
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. The commercialization of the product will generate incremental revenues for company starting FY24 after country-specific registrations are completed.
Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It mainly operates in the regulated markets and has an "in Africa for Africa" strategy and an institutional business to service donor-funded markets.
The company reported a consolidated net loss of Rs 135.89 crore in the quarter ended June 2022 as against net loss of Rs 205.20 crore during the previous quarter ended June 2021. Sales rose 36.56% to Rs 940.07 crore in Q1 FY23 over Q1 FY22.
Shares of Strides Pharma Science rose 1.74% to Rs 318.50 on Friday, 11 November 2022.
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