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.

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Key points

Amgevita FDG

  • 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.

Download a PDF of the formulary discussion guide.

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

Indications

AdultPaediatric 
Rheumatology  
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  
Psoriatic arthritis   
Gastrointestinal  
Crohn’s disease Crohn’s disease (from 6 years of age)
Ulcerative colitis   
Dermatology  
Psoriasis  Plaque psoriasis (from 4 years of age)
Hidradenitis suppurativa  Hidradenitis suppurativa in adolescents from 12 years of age
Ophthalmology  
Uveitis Uveitis (from 2 years of age)

Presentation

Amgevita 40 mg pre-filled pen (SureClick)

Amgevita 40 mg pre-filled pen (SureClick)

Amgevita 40 mg pre-filled syringe

Amgevita 40 mg pre-filled syringe

  • 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.

Amgevita 20 mg pre-filled syringe

Amgevita 20 mg pre-filled syringe

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

Budgetary implications

  • 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

Procurement

  • 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 group1st 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
South East 
Thames Valley and Wessex 
South West 
North East  Amgen: Amgevita* N/A
North West
Yorkshire and Humber 
North London  Sandoz: Hyrimoz® Amgen: Amgevita*
West Midlands 
South London  Mylan: Hulio®* N/A
*Citrate-free
Adapted from Regional Medicines Optimisation Committee Briefing4

Reference pricing

  • 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 strengthReference 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
20 mg £1775.00  £1775.00
40 mg £3550.00  £3662.23 

References

  1. Amgen Ltd. AMGEVITA prefilled pensummary of product characteristics.www.medicines.org.uk/emc/product/9546 (Accessed 5 December 2019)
  2. Amgen Ltd. AMGEVITA prefilled syringesummary of product characteristics.www.medicines.org.uk/emc/product/9547 (Accessed 5 December 2019)
  3. 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/
  4. 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)
  5. Liu J, Eris T, Li C et al. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs 2016; 30: 321–338.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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
  11. NICE. Biosimilar medicines. Key therapeutic topic (KTT15). NICE, 2016 (last updated 2018). Available at: nice.org.uk/guidance/ktt15
  12. NHS England. Prescribed services CQUIN scheme: GE3 hospital medicines optimisation. April 2018. Available at: www.england.nhs.uk/publication/ge3-hospital-medicines-optimisation/
  13. 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

UKIE-P-AMG-0918-067818b

Date of preparation: December 2019