Strategy

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.

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.

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.

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.

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.

As Formycon’s fourth-quarter sales and a key pembrolizumab biosimilar deal become critical to guidance, management hinted that deeper organizational changes may be required.

Despite moves made by other developers to limit biosimilar trials – as regulators around the world move towards more streamlined models – Samsung Bioepis says it is sticking with a Phase III trial program for its SB27 proposed Keytruda (pembrolizumab) rival, having just completed recruitment.

The Italian specialty pharma says an underdiagnosed patient population will drive multi-year growth for its steroidogenesis inhibitor.

Lupin’s US launch of its long-acting risperidone marks the first commercial use of Nanomi’s PrecisionSphere platform, validating a decade-long bet on complex injectables.

Zydus looks to fill up its coffers ahead of the next round of acquisitions, likely in the specialty drugs space, while US FDA approvals for generics to Lynparza and Vumerity and its first approvals in China and Canada point to a healthy pipeline.

Axplora made waves with a recent announcement that the API specialist’s total investments for 2025 would exceed €100m. Anant Barbadikar, co-president of the firm’s PharmaZell business unit, explains how the firm’s strategy is evolving and why he believes the future of pharma remains small-molecule.