In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.
FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.
Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Four companies have confirmed launches of denosumab biosimilars in Europe, setting the stage for a competitive market for Prolia and Xgeva biosimilars.
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
After the recent onset of European biosimilar competition to aflibercept, the next big biologic LOE on the horizon in Europe is denosumab. Several more approvals have just arrived for rivals to Prolia and Xgeva, setting up a fiercely competitive market once biosimilars launch imminently.
Aeon’s cash infusion and upcoming FDA session, now rescheduled for early next year, positions firm to push ABP-450 biosimilar closer to market entry.
As Alvotech continues to reorganize its senior team with the promotion of chief scientific officer Joseph McClellan to chief operating officer, multiple other firms – including Hikma, Hyloris, CNX and Cingulate – have also announced executive updates.
Prestige Biopharma has picked Biosidus to manufacture and export its Tuznue biosimilar rival to Herceptin across four Latin American countries.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
When it comes to predicting the future for generic GLP-1s, Sandoz CEO Richard Saynor believes that “everyone’s asking the wrong questions,” pointing to the importance of manufacturing capacity and ability to supply the, rather than the potential market size, as the key factor.
Deal gives NTC exclusive rights to commercialize Formycon and Klinge’s Baiama aflibercept biosimilar in Italy, expanding Formycon’s growing network of European ophthalmology partners.
Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.
Sandoz has heralded the onset of biosimilar competition to Eylea in Europe with the launch of its Afqlir version. Meanwhile, the firm has also struck up a further ranibizumab alliance with Formycon in Germany.
Amphastar sees two highly likely launches in 2026, with one of them significantly contributing to next year's revenues. However, both generics are yet to be approved by the US FDA.
Approval of Gobivaz across the 30-country EEA introduces long-awaited competition to Simponi, though the partners have yet to confirm a commercial launch date.