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.
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.
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