Accord's SONDELBAY ®▼ (teriparatide) is given Green Light by CHMP
Harrow, England (ots/PRNewswire)
Sondelbay – is a self-administered, once-a-day subcutaneous injection for patients with osteoporosis using a pen device
- Accord's fourth biosimilar, joins the company's established portfolio across Europe, and marks its first branded product in a new Bone Health franchise representing another great milestone in Accord's growing portfolio
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Accord Healthcare (Accord) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation for SONDELBAY (teriparatide) as a biosimilar of the reference product Forsteo® which was first authorised in the EU in 2003.
Sondelbay, is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture
Osteoporosis is a condition where the bones lose their density and structural strength. This can lead to broken bones, pain and disability for the patient. The active substance is teriparatide, as a solution for injection (20 micrograms of teriparatide per 80 microlitres of solution), has shown to have an anabolic (building) effect on osteoporotic bone via the receptor for parathyroid hormone.
Osteoporosis is recognised as a hugely under treated condition, with many patients not getting a diagnosis until they present with a fracture. It was estimated that in 2019 in Europe (European Union, plus Switzerland and UK) 32 million individuals were likely to have osteoporosis, equivalent to a prevalence of 5.6% of the total European population.[1]
Joseph Dunford, Vice President Speciality Brands, Accord, said: "We are proud to launch Sondelbay across Europe, as an addition to our emerging Bone Health franchise. Osteoporosis takes a huge toll not only clinically on the patient, but also on overstretched health systems. This launch reinforces our commitment to continue to improve access to essential medicines for the patients that need them most."
Accord, part of the Intas group, will manufacture the medicine in its own state of the art facility, where they now have the second highest number of biosimilars in phase III to approval in the world.
Notes to editors
- Spokespersons are available for further comment.
About Accord Healthcare
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide.
1. Kanis JA, et al., SCOPE 2021: a New Scorecard for Osteoporosis in Europe, Arch Osteoporos, 2021, 16(1):82.
Contact:
Avril Fudge,
pr@accord-healthcare.com,
+44 (0)7887 471200