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

MovymiaOsteoporosis 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

Movymia
Biosimilar
Thornton & Ross Ltd
Not Known

Development and Regulatory status

Launched
Launched
None
October 2019
Oct 19Launched in the UK. Price: 250 microgram/ml soln for inj: 1 x 2.4ml cartridge plus pen=£235.00; 1 x 2.4ml cartridge=£235.00 [6].
Jan 17Approved in EU [5].
Nov 16EU positive opinion for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture [2].
Nov 16Plans to launch in UK through Internis Pharmaceuticals Ltd (part of the Thornton and Ross/Stada Group) after UK patent expiry [4].

Category

Biosimilar recombinant peptide consisting of a 34-amino acid fragment comprising the biologically active N-terminal portion of full-length human parathyroid hormone (PTH).
In England and Wales, more than 2 million women have osteoporosis. After the menopause, the prevalence of osteoporosis increases markedly with age, from approximately 2% at 50 years of age to almost 50% 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 [1].
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

Evidence based evaluations

LivogivaOsteoporosis

Information

Livogiva
Biosimilar
Theramex
Pfenex

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Aug 20Approved in EU (and UK) [12].
Jun 20Recommended for EU approval by CHMP - approval covers all indications of the originator product: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture [11].
Jun 20At this point, Theramex do not intend to launch Teriparatide PF708 into the UK market [10].
Jun 20Launched in US [13].
Oct 19Pfenex announced on 7 October 2019 that it had received approval from the US FDA for its follow-on teriparatide product (PF708) [9].
Jun 19Theramex currently reviewing decision whether to market in UK [8].
Apr 19Filed in EU [7].
Feb 19The FDA has accepted for review the NDA for PF708 [6].

Category

Hormonal stimulant of bone formation
In England and Wales, more than 2 million women have osteoporosis. After the menopause, the prevalence of osteoporosis increases markedly with age, from approximately 2% at 50 years of age to almost 50% at 80 years of age. More than one in three women and one in five men will sustain one or more osteoporotic fractures in their lifetime [3].
Osteoporosis
Subcutaneous injection

Trial or other data

Jan 18PIII trial due to complete Jun 2018 [4].
Dec 16PIII trial comparing PF708 with Forsteo in patients with osteoporosis is started (NCT03002428) [2].

Evidence based evaluations