Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17

• The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases
• The positive opinion is based on Phase I/III study data investigating the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety
• If approved, CT-P17 would be the first adalimumab biosimilar with high concentration (100mg/mL) and citrate-free formulation

December 10, 2020 06:25 PM Eastern Standard Time

INCHEON, South Korea-- Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira^1, CT-P17 recommending approval for all available indications.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The EC’s decision regarding approval is expected in the first quarter of 2021, which would broaden treatment alternatives for patients suffering from rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV).

“If CT-P17 receives approval by the EC, Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “This portfolio expansion is in line with our mission to improve access to biologics. We aim to provide a wide range of anti-TNF treatment alternatives, together with Remsima^ dual formulation in IV formulation and SC formulation, for patients suffering from chronic inflammatory diseases.”

This positive opinion is based on the phase I/III studies to evaluate pharmacokinetics (PK), efficacy and safety between CT-P17 and reference adalimumab.^2,3 The clinical data support the conclusion of biosimilarity of the proposed biosimilar and adalimumab to the reference product in terms of safety, efficacy, PK/PD and immunogenicity.

A randomised, double-blind phase III study in RA patients demonstrating similarity in terms of efficacy, pharmacokinetics (PK) and safety, including immunogenicity up to 24 weeks was presented at the ACR Convergence 2020.⁴ CT-P17 met the primary objective of demonstrating equivalent efficacy and its safety profile was comparable to that of reference adalimumab.

Further, a randomised, double-blind, single-dose study phase I study demonstrated PK and safety equivalence of CT-P17 in comparison to EU-approved adalimumab (EU - adalimumab) and US- licensed adalimumab (US - adalimumab) in healthy subjects up to 10 weeks. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.²

Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada said, “The CHMP positive opinion is very encouraging as CT-P17 has demonstrated promising study results in efficacy, PK and safety profile compared to reference adalimumab. Also having a high-concentration and citrate-free formulation would provide patients less pain during administration leading to improved quality of life.”

The EC takes binding decisions on the authorisation of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved, the EC will grant a centralised marketing authorisation valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.