Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.

Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.

Sandoz has fired a defensive shot in a US court against the potential that it may have to fork up higher rebates for two of its drugs via the Centers for Medicare & Medicaid Services’ Medicaid drug rebate program – six years after the suggestion was first made.

Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.