Richter’s teriparatide biosimilar gets ‘positive’ opinion
Photo by LaMography / Moni Lazar
Hungarian drugmaker Gedeon Richter Plc. has received a “positive” opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorization be granted for its teriparatide biosimilar, according to an announcement sent to the Budapest Business Journal.
(Photo: LaMography/Moni Lazar)
Upon approval, Terrosa (Richter’s name for its biosimilar) is expected to be used in the same indications as its reference product, Elli Lilly’s Forsteo, i.e. for the treatment of osteoporosis in men and in post-menopausal women with a high fracture risk, the statement says.
The biosimilar, which was developed by Richter, is expected to be launched under both Richter and STADA labels in geographical Europe following the patent expiry of the original product, according to the relevant license agreements.
CHMP’s positive opinion was based on data collected from analytical, pre-clinical and clinical studies related to the development program of the Terrosa. “The positive CHMP opinion for our first biosimilar, teriparatide, marks an important milestone for our biosimilars business. Richter is building upon its expertise in developing and manufacturing biologics by bringing forward these important therapies. Biosimilars will increase choice and access for patients in the EU, while providing potential cost savings to healthcare systems,” said Erik Bogsch, Richter’s managing director.
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