Celltrion receives CHMP positive opinion for 4 biosimilars

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends approval of Celltrion’s Actemra, Eylea, Prolia, and Xgeva biosimilars.

Celltrion announced on the 16th that the.

 

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorizations for its 4 biosimilar candidates.

 

With the recommendations, Celltrion’s 4 biosimilar versions for Actemra, Eylea, Prolia, and Xgeva are expected to be approved in Europe.

 

The biosimilars are named Avtozma, Eydenzelt, Stoboclo, and Osenvelt, respectively.

 

Avtozma is a biosimilar version of the original Actemra, which is used to treat autoimmune diseases such as rheumatoid arthritis and giant cell arteritis.

 

Celltrion’s biosimilar demonstrated bioequivalence and similarity to the original in a global Phase III clinical trial.

 

The original Actemra posted global sales of approximately KRW 4 trillion last year.

 

Eylea, the original version of Eydenzelt is used to treat ophthalmic conditions such as (wet) age-related macular degeneration (AMD), retinal vein occlusion macular edema, and diabetic macular edema.

 

It generated global sales of about KRW 12 trillion last year.

 

Stoboclo and Osenvelt are biosimilar versions of Prolia and Xgeva, respectively.

 

Prolia and Xgeva are based on different doses and dosing intervals of the active ingredient denosumab.

 

Prolia is approved for the treatment of osteoporosis and Xgeva is approved for the prevention of skeletal-related events in patients with bone metastases and the treatment of giant cell tumors of the bone.

 

Together, Prolia and Xgeva generated KRW 8 trillion in sales last year.

 

If Celltrion’s 4 biosimilars receive marketing authorization in Europe, Celltrion will be able to achieve its goal of securing 11 products in its portfolio by 2025.

 

Celltrion currently has received approval or recommendation for approval for 11 biosimilars: Remsima, Remsima SC, Zymfentra, Yuflyma, SteQeyma, Avtozma, Herzuma, Truxima, Vegzelma, Omlyclo, Eydenzelt, Stoboclo, and Osenvelt.

 

The global market size for all of the original products is nearly KRW 13.5 trillion.

 

A Celltrion official said, “It is rare for the CHMP to recommend marketing authorization of 4 products from a single company at the same time, which became an opportunity for us to demonstrate our technology and development capabilities globally.

 

We look forward to completing the remaining marketing authorization process and commercializing our products in Europe.”