Type of information: Granting of a Market Authorisation in the EU
Product name: Amjevita™/Amgevita™ - ABP 501 (biosimilar version of Humira® (adalimumab)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Action mechanism: biosimilar/monoclonal antibody. ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-alpha monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).
Company: Amgen (USA - CA)
Disease: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older
- • On March 23, 2017, Amgen announced that the European Commission has granted marketing authorization for Amgevita™ (biosimilar adalimumab) in all available indications. The product is authorized for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis ; severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. The EC also approved Amgevita™ for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
This approval is Amgen's first biosimilar approval by the European Commission. It is based on a data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity of Amgevita™ were also comparable to adalimumab.
- • On September 23, 2016, the FDA approved Amjevita™ (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases (moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis). Amjevita™ is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Amjevita™ is the fourth FDA-approved biosimilar and the first adalimumab biosimilar approved by the FDA . Amjevita™ is also Amgen's first biosimilar to receive regulatory approval. The FDA’s approval of Amjevita™ is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. It has been approved as a biosimilar, not as an interchangeable product.
- The most serious known side effects with Amjevita™ are infections and malignancies. The most common expected adverse reactions with Amjevita™ are infections and injection site reactions.
- Like Humira®, the labeling for Amjevita™ contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
- • On January 25, 2016, Amgen announced that the FDA has accepted for review Amgen's Biologics License Application (BLA) for ABP 501.The BLA, submitted on Nov. 25, 2015 , is based on analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission. The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 , for ABP 501.
- • On December 4, 2015, Amgen announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501. Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the European Union . Amgen's MAA submission includes analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.
Submission of marketing authorization application USA : 2015-11-25
Submission of marketing authorization application UE: 2015-12-04
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-09-23
UE authorization: 2017-03-23
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: