Celltrion set to begin clinical studies on Humira biosimilar
[THE INVESTOR] Celltrion said on Aug. 7 that it has submitted an application to UK health regulators to initiate phase 1 clinical trials of CT-P17, its copy version of the world’s top selling drug Humira.
Humira is AbbVie’s anti-inflammatory drug that generated sales of US$18.4 billion in 2017.
Having filed its application with the UK Medicines and Healthcare Products Regulatory Agency, Celltrion said the phase 1 clinical program will immediately begin in the UK to evaluate the drug candidate’s safety and pharmacokinetics. Simultaneously, CT-P17 will undergo phase 3 studies at 75 sites in eight countries from this month, aiming to complete it by 2020.
“We have been discussing the clinical trials design with global health regulators to pursue two stage studies during the same period,” a company official said. Industry watchers say this development will help strengthen Celltrion’s biosimilar portfolio.
Celltrion, home to the world’s first biosimilar monoclonal antibody Remsima, has been lagging behind its rivals in developing Humira’s biosimilar version. Samsung Bioepis, Amgen and Boehringer Ingelheim have already completed clinical studies on their respective versions of the AbbVie’s mega-blockbuster therapy and have cleared regulatory hurdles for sale in the US or EU.
Still, Celltrion believes its drug candidate will have room to win market share over biosimilar competitors despite its late development process, given that the company referenced AbbVie’s new formulation of the drug that has higher concentration, which enables a smaller injection volume. The approved biosimilar products reference AbbVie’s older version.
In addition, the original drug maker AbbVie signed deals with Amgen and Samsung Bioepis to delay their US launch of Humira biosimilars until 2023, which will give Celltrion some time to catch up.
The two companies are expected to release their products in the EU market this October as the original drug's patent lapses in the region.
By Park Han-na (email@example.com)