Phil Thomas

The latest updates on EMA product registrations in the last week include:

There are now a significant number of Stelara biosimilars in the market, and competition is likely to be fierce throughout Europe as more tenders are released. It will be interesting to see how prices will stablise as this happenes, and how Stelara pricing will evolve in response.

Two new treatments related to Covid-19. One interesting point is this is the first authorised product for Arcturus Therapeautics. This company has an inhaled mRNA technology product for cystic fibrosis in development, that received orphan designation in February 2024.

There's a trend for launching more Pre-filled Pens, and Wezenla is the latest to add this presentation. Omvoh has added a patient orientated multidose, multistrength option to it's authorised presentations.

Shortages - No changes to the official EU shortages published in the last week.

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.

PharmaFootpath currently shares details on the latest EMA product registration updates through Linkedin, but will start to share through a newsletter too. As subscribers to our company updates, I've added you here too, but feel free to unsubsribe to this newsletter if not relevant, it won't affect receiving the company updates!

Three new products have had marketing authorisation approved, with two new novel products, and the latest Mabthera biosimilar to be launched. Dr.Reddys have added Ituxredi to their portfolio, looking to capture a share of the large Rituximab market.

Jakavi has been a hugelly successful product from Novartis, who have now launched an oral solution presentation for the first time.

Kinpeygo had 4 different pack sizes of the same strength product, they've withdrawn the pack size 100, but the 28, 120 and 360 remain unaffected and continue to be authorised with the EMA

Eldisine is not a centrally registered product, but it's manufacturing challenges affect numerous markets so it is provided as a shortage at the EMA. The reason for shortage is a new manufacturing process being implemented to produce Vindesine, the product API, which is expected to be implemented and providing new stock in September 2025

Both Zirabev and Ecalta had batches produced with quality issues that were all destroyed before reaching the market, resulting in a gap in production plan. Shortages are expected, but may not affect all markets equally.

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Phil

P.S. Please feel free to email suggestions for improvement too!

I'm pleased now to be returning to expanding our data to new markets, with Finland the latest addition! (Adding Lapland and Santa at this time of year felt appropriate!)

Earlier this year we were adding new markets regularly, but this slowed down in the last few months. This was because we have been revising the way that we collect and process country data, to ensure accuracy of our data with far greater confidence than ever before. We continue to roll this out across the markets we already cover, but can now start to do this in parallel to adding new markets

If you'd like to catch up about all the latest developments, and our plans for 2025, just reply to this email and we'll plan in a call!

All the best,
Phil

Hello!

I'll be heading to ExpoPharm in Munich on the 10th and 11th of October, if you'll be attending please let me know and we can have a catch up! I've plenty of developments in the works for PharmaFootpath, and would love to get your feedback.

I'll also be attending GCSG EU Knowledge Forum in Malta on the 15th, 16th, and 17th of October. Let me know if you'll be at this one too!

Hope to see you soon!

Phil