Strides Pharma Science biologics arm gets EMA nod for osteoporosis drug Kauliv
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.;
Bengaluru: Stelis Biopharma Limited, the biologics arm of Strides Pharma Science Limited, has received a positive recommendation from the European Medicines Agency (EMA) for granting market authorization for the osteoporosis drug Kauliv.
"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," the company stated.
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 pen device options to cater to the global market demand.
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