GLOBAL BIOSIMILAR UPDATES
Celltrion Bolsters Biosimilars Market Position in Italy
Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle d’Aosta, Liguria, and Sardegna. Combined, these contracts cover roughly 10% of Italy’s ustekinumab market. Under the contracts, STEQEYMA® will be supplied to these regions until 2028. STEQEYMA® is approved to treat various inflammatory autoimmune diseases including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Celltrion’s adalimumab biosimilar, YUFLYMA®, has also won bids in three regions of Italy. In Lazio and Lombardia, the contracts are for three years. And in Umbria, the contract is for two years. These recent bids further solidify the YUFLYMA® market position. YUFLYMA® is approved for the treatment of autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
Lastly, Celltrion’s infliximab product, REMSIMATM, also secured contracts in both Umbria and Sardegna, increasing its market position in Italy as well. REMSIMATM references Janssen’s REMICADE®, treating a range of conditions, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn’s disease, and ulcerative colitis.
Denosumab Developments in Korea
This month, Hanmi Pharmaceuticals and Samsung Bioepis entered into an agreement to develop and commercialize a denosumab biosimilar (SB16) referencing Amgen’s PROLIA® in Korea. PROLIA® is indicated for the treatment of osteoporosis.
Meanwhile, this month, Celltrion has slashed the price of its own denosumab biosimilar, STOBOCLO®, by 28% in the Korean market.
Alvotech Acquires Xbrane Biopharma AB’s (“Xbrane”) Operations in Sweden
In the transaction, Alvotech will be acquiring Xbrane’s R&D operations in Sweden, spanning several of its research campuses, and its biosimilar candidate (XB003) which references Cimzia® (certolizumab pegol).
Xbrane’s CEO Martin Amark highlighted that the transaction significantly improves Xbrane’s financial position while allowing the company to focus on maximizing the commercial potential of its other key biosimilar assets, Ximluci® (ranibizumab biosimilar) and Xdivane® (nivolumab biosimilar).
Meanwhile, Alvotech’s CEO, Robert Wessman, emphasized the importance of the transaction in increasing the Alvotech’s presence in Sweden’s growing life sciences sector, and fostering future scientific development and collaboration within the EU.
The deal is expected to be finalized later this month.
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