Lanreotide: Original Ipsen injection devices vs Generic injection devices

Update September 2026

New generic version of Lanreotide is approved by US FDA. I do not yet have confirmation of the injection device. I’ll update in due course but my guess is it will look like and be as efficient as the Ipsen version. Click here to read about Amneal Lanreotide.

The Amneal injection device looks identical to the reference drug Ipsen Lanreotide (Somatulie Depot/Autogel) and Cipla’s version

Update 7th September 2024

Following the US FDA approval of Cipla Lanreotide in 2021 using a Pharmathen syringe device (same as currently used by generic versions of Lanreotide in Europe), Cipla have now announced a generic version of their original FDA approval via an Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL subsequently approved by the United States Food and Drug Administration (USFDA). Cipla’s 2024 Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline® Depot (lanreotide) Injection.

Both Cipla Lanreotide products. I suspect the one on the right will be well received. Credit https://ciplalanreotide.com/

I am in US, can I get this generic Lanreotide?

That is a matter for you, your doctors and your insurance system. But see the item particulars including billing code by clicking here.

See the video instructions on how to inject here https://youtu.be/hCWukATxawA

Author’s note: If Advanz Pharma is reading this – please note many European patients would like the same please!

Primer – what are generic drugs?

Companies take out exclusive rights called patents on each new drug they discover. If a company has a patent on a drug, only that company can market it under their brand name once it’s been granted a licence.

Once the patent expires, other manufacturers can market generic versions. The generic versions will be the same as the branded medicine because they contain the same active ingredients.

Many medicines have at least 2 different names:

the brand name – created by the pharmaceutical company that made the medicine
the generic name – the name of the active ingredient in the medicine

For example, lanreotide is the generic name. Somatuline Autogel (or Depot) is the brand name. So, if a company makes a generic version, it will still be called lanreotide but the brand name will be different. e.g. Cipla Lanreotide in USA or e.g. MYTOTAC or MYRELEZ or Lanreotide Advanz Pharma in Euorpe (see below).

Novartis’s Sandostatin has been around for a lot longer than Somatuline and has many generic brands on the market. However, Ipsen’s patient for lanreotide expired in 2015 and some generics are now starting to be deployed.

Read more about generic somatostatin analogues by clicking here.

Original article follows

Drug efficacy vs injection efficacy

Whenever I get a chance to talk to a pharma involved in somatostatin analogue injection devices, I tell them one very important thing …… “To the patient, the injection delivery is almost as important as the drug”. I also add that my opinion is based on thousands of comments about the patient experience in my patient online group.

My own experience is based on the use of Sandostatin Acetate (Octreotide) daily shots (the ones where you break an ampule open and suck the drug into the syringe etc). I was pleased to see some later developments in this area such as the BYNFEZIA PEN. However, the use of octreotide daily shots was a short-term solution to prepare me for surgery and this was followed by monthly somatuline autogel (Lanreortide) which I have been prescribed since December 2010 after major surgery. First using the model with the slightly flimsy plunger device which was not particularly conducive to self-inject, followed by the current Ipsen device which was much improved – I will describe going forward as the “Somatuline Autogel syringe”. That was a vast improvement in patient experience and easier for self-inject. I have always been a nurse administered patient.

Does the delivery device matter?

Yes! See the introduction to the post. My patient group has dozens of comments from disgruntled patients who have had a different delivery device forced upon them which some claim is causing anxiety and, in some cases, additional pain. Pharma producing patented or generic versions must list this as a major factor – underestimate the importance of this part of your product at peril.

Many patients self-inject Lanreotide and therefore some thought must be given to the logistics and the ergonomics involved via syringe design and ease of use. Moreover, the same factors must be considered in nurse/third party administered injections. Pharma producing patented or generic versions must list this as a major factor – underestimate the importance of this part of your product at peril.

Do those who carry out injections have a view?

I was interested to read this study published in August 2023. Two lanreotide delivery systems were compared by Nurses. The two devices were the current Ipsen device (Somatuline Autogel syringe) and another device which the study labelled as the Lanreotide Pharmathen syringe. The latter, based on the description in this study appears to the device used by Advanz Pharma (e.g. Lanreotide Advanz Pharma, MYTOLAC, MYRELEZ) in Europe and (initially from 2021-2024) by Cipla in US.

The PRESTO study results are very interesting. It concluded that Nurses strongly preferred the user experience of the Somatuline Autogel syringe over the Lanreotide Pharmathen syringe (86% vs 14%). “Ease of use” and “comfortable to handle” were the most important syringe attributes, and performance rating was significantly higher with Somatuline Autogel versus Lanreotide Pharmathen syringe for all but one attribute (of the 11 attributes tested).

You can read the study in detail here – click on the blue heading below:

An international simulated-use study to assess nurses’ preferences between two lanreotide syringes for patients with neuroendocrine tumours or acromegaly (PRESTO 3) | Journal of Endocrinological Investigation (springer.co)

Fast forward to 2024 and it’s great to see Cipla in US adapt to the Ipsen syringe (or something almost identical when looking at the pictures online) via a new approval in 2024. I hope Advanz Pharma follow suit.

Patient provided pictures

The Ipsen Lanreotide syringe – picture from Ronny Allan

Lanreotide Pharmathen syringe used by Advanz Pharma (picture provide by a NET patient)

What a shame this Ipsen device project was cancelled

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.