Celltrion's Humira Biosimilar approved and set for launch in Europe

Celltrion Healthcare will bring its parent company’s adalimumab biosimilar called Yuflyma to Europe next month. The company is in charge of Celltrion’s businesses overseas, and it will be launching the said biosimilar drug and start its sale in European countries.

The launch of Yuflyma

As per The Korea Herald, Celltrion will introduce Yuflyma in six European regions at first. A company official reportedly said that they will attempt to release the product in Spain this coming June, but this date could still change.

Celltrion’s Yuflyma is said to be the world’s first biosimilar of Humira, the original drug containing adalimumab and made by AbbVie pharmaceutical company, a spin-off of Abbott Laboratories.

In the third quarter of this year, Celltrion Healthcare is aiming to launch the drug in seven additional European countries and will include France and Germany. In the last quarter, it will roll out in three more regions, including Italy.

Approval of Celltrion’s Biosimilar

The European Commission handed down the authorization for Yuflyma in February. The agency approved it for use in Europe for the treatment of patients suffering from 13 chronic inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, pediatric uveitis, juvenile idiopathic arthritis, and ulcerative colitis.

Celltrion Healthcare shared that the company was given the EU marketing authorization for the high-concentration, citrate-free adalimumab biosimilar. It will be sold under the Yuflyma brand name, which was called the CT-P17 when it was still being developed.

The citrate-free and high concentration formulation, which is 100mg/mL, was applied to lessen the dosage of the existing drug by half. In comparison, most of the Humira biosimilars have low concentrations of the drug.

The Center for Biosimilars stated that the approval is notable because even if the European market has many adalimumab biosimilars already, this one coming from Celltrion has no citrate, a substance that is said to make the drug administration painful for patients. Apparently, it was removed to avoid pain.

Celltrion’s entrance into the adalimumab manufacturing also makes it the first to compete in this new market but with a lower-cost biosimilar. Meanwhile, the approval from the EU commission was followed by positive opinions from the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP).