First clinical trial comparing a Biosimilar teriparatide (Osteofortil® Biosidus, Argentina) versus innovator
Biosidus, Argentina-based biotech company, leader in LatAm in the development and production of biosimilars, is proud to announce the results of the first comparative clinical trial of its teriparatide product (Osteofortil®) versus innovator, according to EMA guidelines.
Biosidus, born in 1983, is an Argentina-based biotech company with sales in LATAM and in ROW (Asia, Eastern Europe and Africa) with unique distribution network. We engage in research, development, manufacture and distribution of biosimilar recombinant proteins with a portfolio of 8 high quality brand biosimilars, with 22 brands in use.
Biosidus conducts on-site manufacturing of APIs and finished products in two own facilities and has an attractive pipeline of biosimilars and innovative products.
Teriparatide is an analogue of human parathyroid hormone, used to treat osteoporosis. Development of Osteofortil® (Biosidus, Argentina), a new pharmaceutical product containing teriparatide, was under EMA guidelines for the development of medications. The product is available in the local market since 2012 and MA applications in other countries are currently in process.
We performed a randomized simple blind trial in postmenopausal women with severe osteoporosis comparing efficacy and safety of both formulations of teriparatide: Osteofortil® (Biosidus, Argentina) and Forteo® (Eli Lilly, USA). Endpoints were comparison of percent of change in BMD (L1 -L4 , DEXA ) at six months, P1NP levels , osteocalcin and CTx at months 1 , 3, 6 , 9 and 12, and percentage change in lumbar spine bone density measured at six months TCC. Also, safety was tested by comparing teriparatide generation of anti-antibodies in months 3, 6, 9 and 12 by ELISA, and the incidence of adverse events.
The study concluded that both products increase similarly BMD markers of bone formation and resorption, and both products have similar safety profile. This is the first successful clinical trial comparing a biosimilar of teriparatide versus the innovator.
The results of this comparative clinical trial “Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil® and Forteo®” were presented at the ENDO 2015, San Diego, California, and at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, –WCO-IOF-ESCEO 2015 in Milan, Italy.