dm+d

398823001

Refrigerated Storage

ForsteoEli Lilly

Eli Lilly
Forsteo
20 micrograms/80 microlitres solution for injection in pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Contact Eli Lilly in all other cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company details.

See above
Yes
29 September 2021
London MI Service

New Medicines

Sondelbay Osteoporosis in postmenopausal women and in men at increased risk of fracture, and associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture

Information

Sondelbay
Biosimilar
Accord Healthcare Ltd
Accord Healthcare Ltd

Development and Regulatory status

Approved (Licensed)
Recommended for approval (Positive opinion)
None
Mar 22Sondelbay approved by the MHRA for “treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture" also, "treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture” [3]
Jan 22Recommended for EU approval by CHMP for “treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture" also, "treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture” Sondelbay will be available as a 20 µg/80 µl solution for injection [1].

Category

Biosimilar teriparatide, the active aminoterminal fragment of human parathyroid hormone.
In England and Wales, more than 2 million women have osteoporosis. Prevalence increases markedly with age, from 2% at 50 years of age to >25% at 80 years of age. Around 180,000 fractures presenting each year in England and Wales are the result of osteoporosis. More than one in three women and one in five men will sustain one or more osteoporotic fractures in their lifetime [2].
Osteoporosis in postmenopausal women and in men at increased risk of fracture, and associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture
Subcutaneous injection