South Korea’s Celltrion Healthcare said on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of CT-P17, an adalimumab biosimilar candidate referencing Humira, recommending approval for all available indications.
If approved by the European Commission (EC), Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation.
Celltrion has developed the new formulation to increase marketability as all existing Humira biosimilar products have low concentration.
As a high-concentration and citrate-free formulation would provide patients less pain during administration, the current adalimumab market is expected to be reorganized around high-concentration formulation products after CT-P17 is launched, the company said.
Celltrion filed for marketing authorization of CT-P17 with the EMA in March. The CHMP positive opinion will now be reviewed by the EC, which would give a final marketing approval in one to three months.