Switzerland and Canada mark the first market entries for Formycon’s ranibizumab biosimilar this year, with several anticipated launches in the Middle East later in 2024.

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Final guidance on assessing registries notes responsibility of sponsors to ensure reliability of data from other organizations and reduce loss of participants to follow-up, while final guidance on data standards for RWD acknowledges sponsors may have limited access to a study’s data sources.

All being well, the Italian firm will soon have the results from a late-stage study of evenamide in schizophrenia patients who show an inadequate response to atypical antipsychotics.