Launches

The US FDA approved LIB Therapeutics’ Lerochol (lerodalcibep), a PCSK9-inhibiting protein therapeutic injected once-monthly that does not require refrigeration, for adults with high cholesterol, including those with HeFH.

The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.

The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?

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.

Executives leading the commercialization of cell and gene therapies are informing how the industry approaches everything from manufacturing strategy to physician education.

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.

Generics Bulletin reviews global regulatory developments across the world.

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.