Strides Pharma Science on Monday said the European Medicines Agency has recommended granting market authorisation for Kauliv, an injection intended for the treatment of osteoporosis, developed by its biologics arm Stelis Biopharma.
The EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion, recommending granting marketing authorisation for KaulivTM on November 11, Strides Pharma Science said in a statement.
"Stelis has already licensed Kauliv across 20 markets worldwide and will commence commercial sales starting FY24 as country-specific registrations complete," it added.
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, Strides Pharma said.
For the European markets, Kauliv will utilise 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 Bengaluru, India, and will scale the opportunity globally through a B2B model," Strides Pharma Science said.
"The company has already licensed KaulivTM across 20 countries, and the commercialisation of the product will generate incremental revenues for company starting FY24 after country-specific registrations are completed," it added.