Strides sees Kauliv, a biosimilar to Eli Lilly’s Forsteo, as a ‘significant’ but ‘not a massive product’ as it prepares to register it in multiple countries post a positive opinion from EMA. Meanwhile, more clarity on fund raising for Stelis is expected by March 2023 even as the regulatory timeline for a COVID-19 vaccine from Akston is extended by 2-3 months

Strides Pharma’s biosimilar teriparatide version of Forsteo has been granted a positive opinion by the EMA’s CHMP, setting the firm up for a pan-European marketing authorization along with Viatris’ pirfenidone generic rival to Esbriet and AOP Orphan Pharmaceuticals’ sugammadex generic of Bridion.

The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.

Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.