Date: 2017-08-24
Type of information: Granting of a Market Authorisation in the EU
Product name: Imraldi® - SB5 - biosimilar version of Humira®
Compound: adalimumab
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Action mechanism:
- biosimilar/monoclonal antibody/TNF alpha inhibitor. SB5 is a biosimilar version of Humira® (adalimumab), a tumour necrosis factor alpha (TNF alpha) inhibitor. Adalimumab binds to TNF and neutralises its biological function by blocking its interaction with the p55 and p75 cell surface TNF receptors. This monoclonal antibody also modulates biological responses that are induced or regulated by TNFalpha,including changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, and ICAM-1).
Company: Samsung Bioepis (Republic of Korea) Biogen (USA - CA)
Disease: rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis.
Latest news:
- • On August 25, 2017, Samsung Bioepis announced the European Commission’s (EC) approval of Imraldi®, a biosimilar referencing Humira®i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. Samsung Bioepis becomes the industry’s first to European approvals for biosimilars referencing all three anti-TNF-? blockbusters. Benepali® (etanercept) and Flixabi® (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.
- • On June 22, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Imraldi® intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis. The drug will be available as a 40-mg solution for injection.
- Imraldi® is highly similar to the reference product Humira®
(adalimumab), which was authorised in the EU on 8 September 2003. Data show that Imraldi® has comparable quality, safety and efficacy to Humira®.
- Imraldi® is the third anti-TNF biosimilar in Biogen’s portfolio in Europe, following Benepali® (etanercept) and Flixabi® (infliximab), both of which have since received European Commission approval in January 2016 and May 2016, respectively.
- Today, the anti-TNF market alone accounts for an estimated $9 billion of healthcare expenditures in Europe, of which Humira® accounts for $4 billion. Global sales estimates for Humira® stand at $16 billion in 2017, making it the number-one prescribed biologic therapy in the world. Data were unveiled at the ISPOR 22nd Annual Meeting in Boston showing that biosimilar introduction of the top-three anti-TNF therapies in Europe could result in savings of $11.44 billion by 2020. Of these savings, $3.18 billion could be attributed to prescribing an adalimumab biosimilar referencing Humira®, despite only being approved near the end of the study period.
- Imraldi® is the third anti-TNF candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.
- • On July 18, 2016, Samsung Bioepis announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB5, a biosimilar candidate referencing Humira® (adalimumab). SB5 is Samsung Bioepis’ third anti-TNF-alpha biosimilar candidate submitted for review to the EMA. If approved, the marketing and distribution of SB5 in Europe will be handled by Biogen.
- The MAA for SB5 was based on data derived from a 52-week Phase III study which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. 24-week results showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the adalimumab arm, while the safety profile of SB5 was comparable to adalimumab. At Week 24, 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or adalimumab 40 mg every other week via subcutaneous injection. 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from adalimumab were transitioned to SB5 (adalimumab/SB5) and 129 patients from adalimumab continued to receive adalimumab (adalimumab/adalimumab). At Week 52, the efficacy, safety and immunogenicity profiles remained comparable between SB5/SB5, adalimumab/SB5 and adalimumab/adalimumab with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. After transition up to Week 52, the incidence of anti-drug antibody was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2016-07-18
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-08-25
Favourable opinion UE: 2017-06-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
