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.
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
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:
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
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.
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.
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. Pharmas who produce patented or generic versions must list this as a major factor.
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:
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.
Awaiting a patient provided picture of the 2024 Cipla generic
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