Celltrion secures EU approval for its adalimumab biosimilar
CT-P17 is the first approved adalimumab biosimilar in the EU with a high concentration, low-volume, and citrate-free formulation. Such formulations area said to reduce injection discomfort.
The EC approval of Yuflyma follows the recommendation for marketing authorization issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December last year.
In terms of the administration device, Dr HoUng Kim, head of the medical and marketing division at Celltrion Healthcare, said the South Korean company looked to ensure improved convenience for patients in terms of the administration device - it includes a proper needle size (29G), it is latex-free, which can reduce allergy risk, and the product has a long storage period or shelf life at room temperature.
Earlier this month, he told the Centre for Biosimilars (AJMC) that Celltrion would initiate the pricing and reimbursement [P&R] process in various European countries immediately on receipt of regulatory approval.
“The duration will depend upon each national process and their system, which varies country by country. Considering biosimilar precedents, we assume that this will take place faster than new drug applications.”
The price of CT-P17 will be similar to the biosimilar versions of adalimumab, the Celltrion representative told that publication. “So we anticipate that high concentration and low volume will be an advantage in pricing and market access, as long as we maintain a similar price range compared to the low concentration versions of adalimumab biosimilars.”
Celltrion said it will leverage the EC Decision Reliance Procedure (ECDRP) to minimize the UK launch lead time. The ECDRP is a new regulatory route that speeds up UK launch of medications approved via a centralized procedure in Europe.
The company has also applied for approval in the US, having submitted the dossier CT-PI7 on Yuflyma to the US Food and Drug Administration (FDA) last November.
Approved for use in 13 chronic inflammatory diseases
The EU marketing authorization is based on analytical, preclinical, and clinical studies which demonstrated that Yuflyma is comparable to the reference product, adalimumab, marketed by AbbVie as Humira, including in terms of efficacy and safety.
Based on the results of the pivotal study, the high concentration formulation of Yuflyma has been approved for use in the EU in patients with 13 chronic inflammatory diseases; rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), pediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), pediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and pediatric uveitis (pUV).
EU adalimumab biosimilar market
The European patent for AbbVie’s Humira expired in October 2018, which opened the floodgates for biosimilar products to launch soon after including Amgen’s Amgevita, Biogen’s Imraldi, Sandoz’s Hyrimoz, Mylan’s Hulio, and Fresenius Kabi’s Idacio.
Whilst three of those are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period.
The EU biosimilar market has developed faster than its US counterpart, as the latter is challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.
In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market, finds a review.