Value-Added Medicines

Generics Bulletin previews the most noteworthy and anticipated events for December 2025.

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

Teva is continuing to decide whether to speed up the FDA review time for its proposed long-acting olanzapine injectable, though the company has numerous options for deploying its priority review voucher across a busy late-stage pipeline.

Outlook Therapeutics believes its revised filing addresses the FDA’s sole remaining concern from an August complete response letter, setting up a potential mid-2026 decision on its wet AMD therapy.

Generics Bulletin previews the most noteworthy and anticipated events for November 2025.

Sandoz triumphed across four categories in the Global Generics & Biosimilars Awards 2025, with other winners including Accord, Adalvo, Amneal, Aurobindo, Cencora, Centrient, CNX Therapeutics, Hikma and Samsung Bioepis, as well as the AAM and its Biosimilars Council.

Glaukos’ FDA approval for Epioxa (riboflavin 5'-phosphate) under the 505(b)(2) pathway marks a major advance in keratoconus care, offering a less invasive, epithelium-on alternative that is set to launch in early 2026 with patient access programs.

As the FDA reviews its lead ADHD candidate, a dexmethylphenidate hybrid, Cingulate is pairing scale-up manufacturing with AI-driven marketing to smooth its transition into commercialization.

Xspray Pharma has welcomed an “important milestone” after the FDA agreed to review its proposed hybrid version of Tasigna (nilotinib), which the Swedish firm says has shown a markedly reduced food effect compared to the reference product.

Aspire Biopharma has its eye on key strategic goals in 2025 and 2026, including for its lead candidate, a sublingual high-dose aspirin product that it hopes to position as a first-line emergency treatment for suspected heart attacks.

Registration is open to attend the Global Generics & Biosimilars Awards 2025 in Frankfurt on October 29. Attendance is free, while options are also open to book a table for the night from which to enjoy our prizegiving ceremony.

FDA approval of a new indication for Teva’s risperidone long-acting injectable Uzedy expands its reach beyond schizophrenia, unlocking a major growth opportunity in the bipolar I disorder market.