A quieter week for product updates from the EMA, but still some interesting new announcements worth nothing
Two new products launched, one novel treatment, and a diagnostic. The final new product registration of note is the latest Stelara biosimilar to be launched, joining a number of others that have been registered in the last few months. This is bound to result in strong competition in the next 12 months, as more countries release tenders and Stelara loses market share.
Balversa was launched in August 2024 with 11 different variations available. There are 3 strengths were available, 3 mg, 4 mg, and 5 mg. At registration there were a number of different pack sizes available, now Janssen have reduced this down to 5 authorised presentations;
3 mg - packs size 56 and 84
4 mg - pack sizes 28 and 56
5 mg - pack size 28
There's unlikely to be any negative impacts for this to companies or patients working with this product.
Shortages - No new updates on centralised shortages in the last week. There are 13 ongoing EU level shortages in announcement, with Ixairo supposed to end immninently according to the last update, though this was a year ago. Such announcements are not always a reliable indicator however, with Fasturec expected to be resolved according to the MAH in June 2024, but remains an ongoing shortage.
PharmaFootpath news:
We're pleased to announce we now cover two further key markets, the USA and Switzerland! Please get in touch if you'd like to discuss these in more detail.
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