Launches

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.

Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.

Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list.

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

The US FDA approval of Fujirebio’s Lumipulse should boost access to medicines like Eisai’s Leqembi and Lilly’s Kisunla; the firms are praising patients’ access to earlier diagnoses.

Eisai spent most of its FY24 earnings call discussing plans for growing sales of Biogen-partnered Alzheimer’s drug Leqembi from JPY44.3bn ($304.1m) to JPY76.5bn ($525.1m) in FY25.

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

Vertex is in need of diversification, but in addition to its lower-than-expected Q1 revenue, sales of the company’s newest CF drug Alyftrek and pain medicine Journavx disappointed.