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Phil Thomas

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EMA product updates - 14th Feb


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Kinpeygo had 4 different pack sizes of the same strength product, they've withdrawn the pack size 100, but the 28, 120 and 360 remain unaffected and continue to be authorised with the EMA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


This is a new newsletter, so please share it with anyone you think would benefit from it. They can sign up using the footer below!

Phil

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

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Finland data now available!



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

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Heading to ExpoPharm/GCSG

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

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Creating a shortlist of new suppliers to get an edge

When searching through Pharma Footpath for a product you may not have sourced very often, or even entirely new, you can sometimes find that a suprising price in a market you don't have strong relationships. What then?

Using the EU WDA License tool in Pharma Footpath gives you chance to review who has licenses in different markets, and the conditions on their licenses!

Search WDA licenses in Pharma Footpath

Let's imagine you need a cold chain product, and you've seen the list price information in Greece suggests this might be a good market to speak to suppliers. It's not a market you've strong relationships with, so you're looking for all options. By applying a couple of simple filters, you can select all WDA license holders in Greece who have both 'cold chain' as a license condition, as well as 'export'.

Select license conditions in dropdown

In which case, you only have 48 WDA license holders that meet these conditions. Some of these may be irrelevant, logistics providers for example, and now you're left with a shortlist of companies to evaluate and see whether there are potential new partners.

This may take a little bit of time to evaluate, but this time invested expands your network and can reveal some opportunities that competitors haven't taken the time to explore!

If you'd like to discuss more about the information in WDA licenses, or how we can use data to enhance your business, please reply to this email and let's discuss!

Phil

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Italian parallel import market

Some markets are more difficult to gather detailed information from, and the Italian market falls in that category. That means that when we do run analytics on the market, it's important to share!


- 1,482 parallel trade licenses have been granted to bring stock into Italy, though 248 are no longer commercialised.

- 17 different companies hold these licenses. GMM Farma being the biggest with 269 licenses approved, including 24 licenses granted in 2024.

- Bayer's oral contraceptive Yasmin is the most contested parallel import product, with 12 different companies holding PI licenses for this.

- Of the 223 different products imported (that is, excluding different strengths and pack size variations), 67 are held by a single company without competition.

- In line with the wider PI industry, the number of licenses granted per quarter has increased steadily over the last 10 years. From an average of 9.75 licenses per quarter in 2013, to 48 per quarter in 2023.

Italian Parallel Import licenses granted per quarter since 2014

The rise in competition for parallel import products, and the growth in the industry more broadly, has resulted in companies looking for a new 'edge' that allows them to compete more effectively. Pharma Footpath has been working with parallel import companies to identify new opportunities before others, and track competition more effectively.

If you're interested in seeing what data analytics we can provide for your business, you can reply to this message and let me know what you're keen to learn more about!

Phil

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