Urtė Fultinavičiūtė

Online health platform Hims & Hers will sell Apotex's generic semaglutide in Canada but is only offering off-label prescriptions for weight loss.

A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.

Hikma has secured victory in the long-running litigation with Amarin over skinny-label generic carve-outs. While the SCOTUS decision preserved the skinny-label regime, the grounds will be tested by future litigations.

With a $135m Canadian market opportunity and Celltrion as the only approved rival, Kashiv's filing targets a competitive but not yet crowded omalizumab biosimilar landscape.

Regeneron's CFO Christopher Fenimore has outlined intentions to “extend Dupixent's marketing exclusivity for as long as we can,” as the list of upcoming biosimilar competitors keeps growing.

With its full-year guidance now confirmed, Formycon's numbers are moving in the right direction after a difficult 2025.

Organon closes an indication gap with Tofidence, but subcutaneous availability and market share remain areas where its tocilizumab biosimilar still lags behind.

Generics Bulletin senior reporter Urtė Fultinavičiūtė talks to Tahir Amin, co-founder and CEO of I-MAK, about the current intellectual property system that curtails off-patent drug competition and global health equity.

Samsung Bioepis and Organon have expanded their partnership with the addition of a sixth biosimilar, Pyzchiva (ustekinumab).

At $12,750 per year versus $370,000 for Trikafta, Beximco's generic is now in patients' hands, with orders placed from June scheduled for November distribution via a single authorized global supplier.