Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.
Celltrion has become the third firm to win US Food and Drug Administration approval for biosimilar denosumab rivals to Prolia and Xgeva, with the agency approving the Korean developer’s CT-P41 candidate as Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), covering all indications of the respective brands.
Denosumab is one of the major molecules set to face biosimilar competition this year. Amgen’s two reference brands currently represent...
As Alvotech announced first-half results that outpaced expectations, the biosimilars developer’s management explained that the firm was targeting value and product margin over market share and volumes.
Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
With H1 revenues not even hitting double-digits, Formycon is bidding on partnerships and royalties to generate at least €46m over the next half-year to reach its revenue goal.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.
With H1 revenues not even hitting double-digits, Formycon is bidding on partnerships and royalties to generate at least €46m over the next half-year to reach its revenue goal.
