Information intended for healthcare professionals only.
This formulary discussion guide was developed from content provided by Amgen Ltd in a format developed by Guidelines in Practice.
- Amgevita® is a biosimilar of adalimumab
- Amgevita is citrate-free1,2 and available as three different presentations, including a single dose pre-filled pen (SureClick®)
- In 2017/18, the NHS spent an estimated £400 million on the adalimumab reference product (RP);3 the introduction of biosimilars has the potential to provide considerable cost efficiencies
- Amgevita 40 mg is available as first choice in three regions and as second choice in seven regions, with a 20 mg option available in all 11 regions4
- From the adalimumab tender strategy, regions allocated a biosimilar that contains citrate as their first choice will also have access to a citrate-free option as a second choice4
- A patient support package is available for all patients; it includes a patient pack and access to a video on how to use Amgevita (www.amgencare.co.uk/amgevita) and is received on their first home care delivery; NHS staff training can be arranged by a local Amgen Account Manager
- Amgen invests in transition support via homecare providers, including dedicated project managers, nurse training, and telephone counselling for patients, as well as stock checks and delivery reporting to support a smooth transition to Amgevita.
Drug name and formulation
Amgevita®▼ (adalimumab biosimilar)
- Amgevita is citrate free
- Excipients include glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide, and water for injections.1,2
|Rheumatoid arthritis||Polyarticular juvenile idiopathic arthritis (from 2 years of age)|
|Ankylosing spondylitis (AS)||Enthesitis-related arthritis (from 6 years of age)|
|Axial spondyloarthritis without radiographic evidence of AS|
|Crohn’s disease||Crohn’s disease (from 6 years of age)|
|Psoriasis||Plaque psoriasis (from 4 years of age)|
|Hidradenitis suppurativa||Hidradenitis suppurativa in adolescents from 12 years of age|
|Uveitis||Uveitis (from 2 years of age)|
- Amgevita is available as three different presentations: two single dose pre-filled syringes (40 mg solution and 20 mg solution)2 and a single dose pre-filled pen (SureClick® 40 mg)1
- The dosing schedule for the above indications and administration are the same as for the reference product; see the Summary of Product Characteristics1,2 for more dosage information.
Evidence for use
- Amgevita has demonstrated similarity to the adalimumab reference product in terms of quality, efficacy, and safety parameters.5,6,7,8,9
- In 2017/18, the NHS spent an estimated £400 million on the adalimumab reference product;3 the introduction of biosimilars has the potential to provide patients with access to a wider range of more cost-effective treatments10
- NICE key therapeutic topic (KTT15) states that ‘biosimilar medicines have the potential to offer the NHS considerable cost-savings and widen the access to innovative medicines11
- NICE KTT15 also recommends prescribing biosimilars by brand name to ensure the patient receives the intended product and substitutions are not made at the point of dispensing11
- The ‘Hospital Medicines Optimisation CQUIN scheme GE3’ has set a target for 2018/19 for patients to receive best value generic or biological products. The aim is that at least 90% of new patients will be prescribed the best value biological medicine, and at least 80% of existing patients within 12 months, or sooner if possible.12
- NHS England put a national framework in place for the supply of adalimumab injections, dividing the available market into 11 regional groups of providers
- Amgevita 40 mg is available first line in three regions and second line in seven regions, with a 20 mg option available in all 11 regions.4
|Regional group||1st line 40 mg biosimilar||2nd line 40 mg biosimilar||20 mg/0.4 ml biosimilar||Originator product award|
|East Midlands||Biogen: Imraldi™||Amgen: Amgevita*||Amgen: Amgevita*||AbbVie: Humira®*|
|East of England|
|Thames Valley and Wessex|
|North East||Amgen: Amgevita*||N/A|
|Yorkshire and Humber|
|North London||Sandoz: Hyrimoz®||Amgen: Amgevita*|
|South London||Mylan: Hulio®*||N/A|
Adapted from Regional Medicines Optimisation Committee Briefing4
- Adalimumab is currently excluded from the national tariff (as is the case for many high-cost medicines)
- From April 2019, NHS England expects CCGs to use the adalimumab suppliers allocated to their regional group; reference prices will be used to reimburse providers and replace any current pass-through payments,13 and the reimbursement will be the same irrespective of the medicines allocated to their region
- The reference price is applicable to all patients being treated with adalimumab and is intended to support the uptake of the best value biologics for each regional group; it also ensures that patients are able to access a citrate-free product where clinically required and that providers are fully reimbursed for their costs13
- Any trust that does not transition to a biosimiilar will be potentially financialy disadvantaged.
|Dose strength||Reference price set for 2019/20|
Regional groups (except South London) per patient per year (pro rata) including homecare costs13
|Reference price set for 2019/20|
Regional group South London per patient per year (pro rata) including homecare costs13
- Amgen Ltd. AMGEVITA prefilled pen—summary of product characteristics.www.medicines.org.uk/emc/product/9546 (Accessed 5 December 2019)
- Amgen Ltd. AMGEVITA prefilled syringe—summary of product characteristics.www.medicines.org.uk/emc/product/9547 (Accessed 5 December 2019)
- NHS Commissioning Support. Toolkit for implementing best value adalimumab. Updated August 2018. NHS Specialist Pharmacist Service. Available at: www.sps.nhs.uk/articles/adalimumab-toolkit-for-commissioners-and-providers/
- NHS England. Regional Medicines Optimisation Committee Briefing. Best Value Biologicals: Adalimumab Update 5 (revised).www.sps.nhs.uk/articles/rmoc-briefing-on-adalimumab-december/ (Accessed 5 December 2019)
- Liu J, Eris T, Li C et al. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs 2016; 30: 321–338.
- Kaur P, Chow V, Zhang N et al. A randomsed, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis 2017; 76: 526–533.
- Cohen S, Genovese M, Choy E et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis 2017; 76: 1679–1687.
- Papp K, Bachelez H, Costanzo A et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017; 76 (6): 1093–1102.
- Papp K, Bachelez H, Costanzo A et al. Clinical similarity of biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol 2017; 177 (6): 1562–1574.
- British Society for Rheumatology. Position statement on biosimilar medicines. January 2017. Available at: www.rheumatology.org.uk/Knowledge/Influencing-Policy-and-Parliamentary-Affairs/Policy-position-statements
- NICE. Biosimilar medicines. Key therapeutic topic (KTT15). NICE, 2016 (last updated 2018). Available at: nice.org.uk/guidance/ktt15
- NHS England. Prescribed services CQUIN scheme: GE3 hospital medicines optimisation. April 2018. Available at: www.england.nhs.uk/publication/ge3-hospital-medicines-optimisation/
- Swindells M. Reference prices for adalimumab. London: NHS England and NHS Improvement, 2019. Available at: www.england.nhs.uk/wp-content/uploads/2019/04/reference-prices-for-adalimumab-letter.pdf
Imraldi™ is a trade mark of Biogen
Hyrimoz® is a registered trade mark of Sandoz
Hulio® is a registered trade mark of Mylan
Humira® is a registered trade mark of AbbVie
Date of preparation: December 2019