Earnings
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
The Italian specialty pharma says an underdiagnosed patient population will drive multi-year growth for its steroidogenesis inhibitor.
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.
Formycon continues preaching its confidence that it will meet the full-year guidance, despite facing a steep revenue void of €35.5m needed to meet the target.
Biocon’s biosimilar and generic businesses both delivered double-digit revenue increases, with non-US markets increasingly playing a more important role in the growth strategy.
Supply-chain bottlenecks, heavy wholesaler de-stocking, and tighter working-capital controls sent Gedeon Richter’s General Medicines sales down by 17% and slashed adjusted EBIT by nearly two-thirds in Q3.
Capital tightening and shifting US regulations slowed contract manufacturing orders in Q3, though Richter sees normalization ahead as new European clients come online.
Sun’s specialty gambit reaps gains with US sales surpassing generics for the first time in Q2 FY26, but will it finally enter the fray for biosimilars as the US moves to simplify regulatory requirements in the segment?
Favorable regulatory winds in the US are leading Lupin down the biosimilar path, as it also hopes that the potential US generic-first policy will boost its wider off-patent drug portfolio. However, it is also facing several facility compliance setbacks.
Spun out of Mallinckrodt following its merger with Endo, Par Health begins operations as a major US producer of generics, sterile injectables and APIs, while Mallinckrodt’s remaining branded arm rebrands as Keenova Therapeutics.
Do US FDA’s efforts at simplifying the biosimilar pathway create more competition and threaten Aurobindo Pharma's return on investments? Management speaks on this, biosimilar filing plans and deal strategy at the Q2 FY26 earnings call.
Hikma has set out expectations for its nascent biosimilars business in the US, after launching its Bio-Thera-partnered Starjezma rival to Stelara through Mark Cuban’s Cost Plus Drug Company. Meanwhile, a trading update issued by the firm has pointed to a slight decline in Injectables margins.
Fresenius has acknowledged that the FDA’s draft guidance could shorten approval timelines and cut trial costs for biosimilars, even though it “may have not fundamentally changed the existing framework.”
Viatris says initial corrective work at its oral solid dose site in India is “substantially complete” and that it has met with the FDA to discuss next steps following last year’s warning letter and import alert.
Amneal continues to see biosimilars as an attractive but competitive space, with vertical integration in the US market being a key to its success.
Teva has ended exclusive talks to sell its active pharmaceutical ingredients arm after failing to reach terms that aligned with its strategic and shareholder interests, but plans to relaunch the process as shifting geopolitical and market conditions renew buyer interest.
Amgen’s CEO Robert Bradway has reaffirmed confidence in the company’s Humira biosimilar, Amjevita, as the company tackles with an ever-growing population of denosumab biosimilars.
Cipla’s global CEO and MD Umang Vohra is moving on handing over the baton to global COO, Achin Gupta. Vohra talks about his innings, where he sees Cipla in 2030 and the impact of the latest FDA action that aims to make biosimilar development faster and less costly.
On its third-quarter earnings call, Biogen’s management said the company remains well positioned despite accelerating generic pressure in Europe and the imminent US launch of Sandoz’s Tyruko biosimilar.
Expounding on the scale of the potential opportunity for biosimilars developers as the firm delivered its third-quarter results, Sandoz also set out launch plans for denosumab and aflibercept in Europe, as well as natalizumab in the US, by year-end.