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Celltrion expands market presence in Italy with autoimmune disease biosimilars

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Celltrion is strengthening its position in Italy, one of the five major European pharmaceutical markets, by securing key bids for its autoimmune disease treatments.

Celltrion secures key pharmaceutical bids in Italy, strengthening its market presence with biosimilars for autoimmune disease treatments.

Celltrion secures key pharmaceutical bids in Italy, strengthening its market presence with biosimilars for autoimmune disease treatments.

Celltrion’s Stelara (ingredient: ustekinumab) biosimilar, Steqeyma, launched in January this year, has made an immediate impact by winning its first bid within two months.

Stelara, developed by Johnson and Johnson Innovative Medicine, treats various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

The company’s Italian subsidiary secured contracts in four regional tenders across Piemonte, Valle d’Aosta, Liguria, and Sardegna, covering approximately 10 percent of Italy’s ustekinumab market. Under these agreements, Steqeyma will be supplied in these regions until 2028.

Celltrion’s Humira biosimilar (ingredient: adalimumab), Yuflyma, has also won bids in three strategically important regions—Lazio, Lombardia, and Umbria. As a result, Yuflyma will be supplied in Lazio and Lombardia for three years and in Umbria for two years, starting this month.

According to IQVIA, a pharmaceutical market research firm, Yuflyma led the Italian adalimumab biosimilar market with a 43 percent market share as of the third quarter last year.

AbbVie's Humira, the original medicine, is prescribed primarily for autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

The drug saw a notable 5-percentage-point increase in market share over the previous quarter, further widening the gap with competitors.

With the latest bid wins, Yuflyma is expected to solidify its position as the leading prescription treatment in its category.

Celltrion’s flagship infliximab product line, including Remsima (IV and SC formulations), is also expanding its market presence.

Remsima, referencing the original drug Remicade, developed by Janssen, is designed to treat a range of conditions, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn's disease, and ulcerative colitis.

Remsima recently won a tender in Umbria, securing a two-year supply contract until 2027, and Remsima SC, the world’s only subcutaneous formulation of infliximab, has gained a new market opportunity in Sardegna.

Previously, Sardegna was the only Italian region without an infliximab SC bid system. With this addition, all regions across Italy now have tender processes in place for Remsima SC, paving the way for stable revenue growth as the only product in its category with no direct competition.

The success of the Remsima product line is translating into strong prescription figures. In the third quarter of last year, the combined market share of Remsima IV and SC in Italy stood at 56 percent, maintaining its leadership position for three consecutive quarters. Notably, Remsima SC alone recorded a 21 percent market share, demonstrating steady growth.

Celltrion attributes its success in the Italian market to its strategic shift toward direct sales. Since transitioning to a direct sales model in 2020, starting with Remsima, the company has actively built strong relationships with key stakeholders in Italy’s pharmaceutical procurement system.

By emphasizing product competitiveness and supply stability, and minimizing delivery lead times after bid awards, Celltrion has strengthened trust in its products and operations.

“You can see the tangible results of our direct sales transition in 2020, as we continue to secure bids across Italy,” Celltrion's Italy Subsidiary Regional General Manager Yoo Won-sik said. “Our autoimmune disease treatments, including the Remsima product line and Yuflyma, are leading the market by outpacing competitors.”

Leveraging the same distribution and operational networks as its existing products, the company will ramp up its efforts to position Steqeyma as the leading prescription choice in its category, Yoo added.

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Lee Han-soo corea022@docdocdoc.co.kr

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