Celltrion’s Stelara biosimilar Qoyvolma gains EU approval

Qoyvolma  is additionally approved following the approval of Steqeyma... secures approval of 2 Stelara biosimilar

”Ulcerative colitis has been newly added as an indication for Steqeyma, accelerating the company’s penetration of the approximately KRW 30 trillion market.”

Celltrion announced on the 9th that ‘Qoyvolma,’ its biosimilar version of the autoimmune disease treatment Stelara (ustekinumab) has received marketing authorization from the European Commission (EC).

 

Qoyvolma has been approved with the addition of ▲'ulcerative colitis (UC)' to the existing indications of ‘Steqeyma,' another Stelara biosimilar previously approved by Celltrion, which is indicated for ▲plaque psoriasis, ▲psoriatic arthritis, and ▲Crohn's disease (CD).

 

With this approval, Celltrion now holds two biosimilars of Stelara.

 

Celltrion plans to strategically leverage the two products with different indications to flexibly address the complex patent landscape across European countries and expand its market share.

 

The company expects that the addition of Qoyvolma will enhance its competitiveness in the ustekinumab market by expanding indications, as Steqeyma’s sales have been growing rapidly in Europe upon its launch.

 

Steqeyma is a new biosimilar treatment that was released in Europe and the US in November last year and March this year, respectively.

 

In Europe, it has been launched in five major countries (Germany, Spain, the UK, Italy, and France) as well as the Netherlands, and has already secured bids in tenders, marking the beginning of its market penetration.

 

In the US, it has signed contracts with two of the top five prescription drug reimbursement management companies (PBMs), which account for about 90% of the total insurance market, and is in negotiations with other PBMs.

 

Celltrion plans to continue expanding its market share in the global ustekinumab market to drive sales growth.

 

According to IQVIA, a pharmaceutical market research firm, the global market size for ustekinumab is estimated to be approximately USD 21.66 billion (approximately KRW 30.32 trillion) as of 2024.

 

A Celltrion official stated, “With the recent approval of Qoyvolma, we will be able to further strengthen our coverage of the ustekinumab market in Europe.

 

Given that Steqeyma, which was launched earlier, is already showing positive growth trends in the global ustekinumab market including Europe, we will make every effort to leverage the complementary strengths of both products to expand market share and drive sales growth.”