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.
Producing journalism that is worthy of the name is a costly business. For over 30 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.
