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Ronny Allan
Generic Somatostatin Analogues.
I’ve covered a lot about somatostatin analogues, particularly the two predominant approved drugs Lanreotide and Octreotide. Recently I found there are some for octreotide and as of Jul 2021, at least one for Lanreotide and is increasing.
The reason for publication of this blog is because I was concerned to hear patients asking questions about generic lanreotide and octreotide in my private Facebook group where they were suggesting they could be of lesser quality. I studied that in more detail and here are the results of that research.
What are generic drugs?
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:
- 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 Lanreoride e.g. e.g. Advanz Pharma’s lanreotide known MYTOTAC or MYRELEZ or Lanreotide Advanz Pharma depending on the country where the drug is used (see Lanreotide section below).
Detail
According to the US FDA, a generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
This is not a new idea, many well-known household brands are in fact generic medicines, take the well-known drug paracetamol as an example. You can buy many “branded” versions of paracetamol in UK e.g. each Pharmacy and Supermarket has their own branded version of the same drug. Similarly, in US the drug Acetaminophen in USA, it is produced in many different generic brands e.g. Tylenol, Tempra, and Panadol.
I also checked the UK NHS and the European Medicines Agency (EMA) and found their descriptions to be similar. All of these organisations emphasised the same things:
1. A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s). The active substances are the original medication.
2. A generic medicine’s inactive ingredients, name, appearance and packaging can be different. Different trade laws will influence how this works in different countries. e.g. trademark laws in the US do not allow a generic drug to look exactly like other drugs already on the market.
3. Even though they contain the same reference drug, generic medicines still need to go through an approval process. This is an important point as the less scrupulous online sites selling generic drugs may not have the same levels of approval rigour. See my warning below.
4. Generic drugs tend to be cheaper because applicants do not have to repeat animal and clinical (human) studies and other development costs that were required of the brand-name medicines to demonstrate safety and effectiveness. When multiple generic companies are approved to market a single product, more competition exists in the marketplace, which typically results in lower prices for patients. Sometimes it even forces the original patent holder to reduce their own prices to remain competitive.
WARNING!
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of medications. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your healthcare provider for advice if you are unsure about the online purchase of any medication.
What are the generic somatostatin analogues for Octreotide?
As of 3 Oct 2024
Long acting
- 3rd October 2024. Teva Announces Launch of the First and Only Generic Version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension), in the U.S. Read more here. From what I am reading, this is likely to be price competitive.
- It is branded as “Octreotide (Olatuton®)” at least in UK. Read about Olatuton® in the UK here. Olatuton in UK may be halted due to a commercial dispute (confirmation to follow).
- Ratiopharm. Ratiopharm is a German pharmaceutical company that is Europe’s leading generics brand (parent company is TEVA above). It has a long-acting octreotide branded as “Octreo-ratiopharm®“. Appears to be in use in various EU countries including Germany and Finland according to patient feedback. Read more here.
- I believe Teva already has a generic Octreotide long acting in Canada.
Short acting
- Bynfezia Pen. Manufactured by Sun Pharmaceutical Industries Ltd, India for use in USA. This is octreotide acetate branded as Bynfezia Pen. It is not a replacement for Sandostatin LAR, it’s for daily/rescue use only. Read more here.
- Pharmaxo. Details to follow
- Octreotide USA. Several companies have their own branded generic octreotide short-acting. These include (but are not limited to) West-Ward, Wockhardt, Heritage Pharm, Sagent Pharm, Sun Pharm, TEVA, Mylan. Will update more in due course. Of course, Novartis continues to supply via its own brands.
What are the generic somatostatin analogues for Lanreotide?
As of 09 Nov 2023
Lanreotide is a much newer drug and so it takes time for the pharma industry to be able to legally produce generics. Europe took the lead in rolling them out but see the USA version below.
Advanz Pharma appear to be the current lead supplier of generic Lanreotide in Europe.
Advanz Pharma have confirmed to me:
Mytolac is the brand name in Germany and Netherlands.
Myrelez is the brand name in Denmark, Finland, Norway, France, Spain and Turkey.
Lanreotide Advanz Pharma is the name in UK. Read approval here. Many UK trusts are rolling out Lanreotide Advanz Pharma on cost grounds. e.g. NHS indicative price for 120mg is £749.60 vs Ipsen’s Somatuline Autogel indicative price of £937.
What is the drug indicated for?
Lanreotide solution for injection is used for:
– the treatment of acromegaly (a condition where the body produces too much growth hormone)
– the relief of symptoms such as flushing and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NETs)
– the treatment and control of the growth of some advanced tumours of the intestine and pancreas called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours cannot be removed by surgery.
Storage Instructions for Lanreotide Advanz Pharma
The Advanz Pharma patient information leaflet (PIL) storage instructions are different to the Ipsen leaflet in that:
“[…] Store Lanreotide Solution for Injection in a refrigerator (2°C – 8°C) in the original package in order to protect from light.
Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator (the number of temperature excursions must not exceed three times) for continued storage and later use, provided it has been stored for no longer than a total of 24 hours at below 40 °C. […]”
The Ipsen PIL was amended recently to allow 72 hours at below 40 °C. I have written to Advanz Pharma and they are looking at ways to update the leaflet for Lanreotide Advanz Pharma with the following comment “We are currently evaluating the possibility to submit a variation to the regulatory authorities aligning our PIL to the reference product regarding the allowed time period at below 40 °C.”
The Injection Device for generic Lanreotide
The injection device selected by Advanz Pharma for all generic Lanreotide is thought to be marketed by Pharmathen. It appears to be a Dali device called SAN-Light. SAN-Light is a unique, single-use sterile hypodermic safety needle that is compatible with any Luer-lock syringe for subcutaneous or intramuscular drug administration. It is part of DALI’s SAN® (Safe Auto Needle) family of safety injectable drug delivery devices, all of which enable “a more safe and easy-to-use injecting experience for a wide range of formulations”. (Pharmathen also supply the injection device for the US generic “Cipla Lanreotide”). Again, this looks like the SAN-Light mentioned above. See Cipla Lanreotide section below.
Update 7th September 2024
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.
Lanreotide: Ipsen injection devices vs generic injection devices
Updated 19th December 2021 – the first “non-Ipsen” version of Somatuline Depot (Lanreotide) in the US
News just in….. the first “non-Ipsen” version of Somatuline Depot (Lanreotide) in the US has been approved by the US FDA according to a press release from the company Cipla. This can often lead to price reductions. The active ingredient, route of administration and strengths are the same as SOMATULINE DEPOT®, from Ipsen Biopharmaceuticals Inc. The injection device in the picture below appears to be the SAN-Light device (Pharmathen) mentioned above (see pictures above). To avoid confusion, the drug should be referred to as “Cipla Lanreotide”.
First generic of Lanreotide for USA? A different route to approval called 505 (b)(2). Same principle though but quicker route to approval. It was not until May 22, 2024, they received full approval from FDA for this generic version.
Read the blue link below.
Cipla receives final approval for the generic version of Somatuline® Depot (lanreotide) Injection 120 mg/ 0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL | Cipla
Mumbai, India, & New Jersey, USA: December 19, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) and its subsidiary Cipla USA, Inc., (hereafter referred to as “Cipla”), today announced that it has received final approval for its Lanreotide Injection, from the United States Food and Drug Administration (US FDA). The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. Lanreotide Injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-dose pre-filled syringes. It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
Umang Vohra (MD and Global CEO, Cipla Limited) said, “We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of “Caring for Life”. This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs.
The active ingredient, route of administration, and strengths are the same as SOMATULINE DEPOT®, from Ipsen Biopharmaceuticals Inc. e.g. it’s a generic drug.
What is the drug indicated for?
There is some controversary (9 Nov 23) that the drug has not been formally approved for any hormonal condition related to NET, having only been approved (indicated) for “the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs),” Cipla said
The wording is unconventional but states that it is a “therapeutic equivalent generic version”.
Read Cipla Lanreotide website here.
Read Instructions for use and a video here.
Presto 3 Study – Somatuline Autogel Syringe vs Lanreotride Pharmathen Syringe
I came across this study which compare nurse experience in both the regular Ipsen provide somatuline injection syringe vs the one in use with generic Lanreotide (known as the Lanreotide Pharmathen syringe). The study confirmed Nurses preferred the Somatuline Autogel Syringe. This is pretty much what I hear from patients too.
Read more here: click here
Clinical Trials
Some of the new delivery systems in a clinical trial will clearly be using generic names and new brands if their product is authorised for marketing. Read more about some of these octreotide-based products here. Most of these fall by the wayside!
Other generics for NET?
PRRT
Everolimus (Afinitor)
Although not a somatostatin analogue, you might be interested in news of a generic for Everolimus (Afinitor) produced by TEVA. Read more here.
Breckenridge Announces Launch of its 10mg strength for Everolimus (Afinitor) Tablets (generic for Afinitor®). Read more here. Breckenridge is a distributor for NatCo Pharma. There are others – read here Generic Afinitor Availability – Drugs.com
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I recently contacted the TEVA Octreotide patient support program here in Canada and was told that they are not taking any new patients because of a shortage of the medication.
so some people in Canada are already receiving TEVA octreotide?
I’m in Canada as well and have been taking the TEVA for almost 3years now. It’s the box that’s green, yellow and white I believe. When they were back ordered for a few months I took the generic one. It’s $2,740.00 less a month but I saw no difference between them symptom wise. Also I don’t have to pay for it but when I pick it up at the pharmacy it always has the cost; then balance zero thankfully
[…] Generic Somatostatin Analogues for Neuroendocrine Cancer Ronny Allan – Living with Neuroendocrine Cancer April 22 2021 […]
I buy Sun Pharma’s Octreotide Depot in India at half the price of Sandostatin LAR of Novartis, always wondering whether it will have the same effect. Now I’m relieved!! Thanks for the information. Your noble service is very much appreciated!
I understood that though the ingredients are the same, the delivery system may be different. I assume that means coating on the pills type of patch for skin, etc. I do have one generic totally unrelated to neuroendocrine cancer which does not impact the same as the name brand, and know a few other medications related to other disorders such as thyroid meds, which do not behave the same way in the body, as name brand.
Thanks Linda, perhaps the checks for Oncology drugs are more stringent. The words used came from FDA.
“These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine”.
If I take a simple generic of “paracetamol” which in UK has many different brands, I honestly can’t see any difference.
Hope you’re doing OK?
Thanks. Yes I am and thanks for your comment. I’m thankful for good medical care plus Sandostatin & Lanreotide over the years. Plus availability of good information. Thank you for your excellent efforts along that line. Be well yourself!
Ronnie – Some years ago i received O and I but the pain and and stiffness these injections caused was Murderous so the doc called a halt to giving them.
Now my back is virtually collapsing and stiff and i was recently told that my small intestine tumour in my terminal ileum is growing and pressing on the surrounding areas causing my back problem – so they reckon!. I will soon be unable to walk
I get nothing from the C specialist and have had appointments cancelled due to the Covid lurgi.
Any suggestion as to where one may get some positive treatment?
Best aye John Parkes
Check out the closest specialists to you, let me know if you need a recommendation https://ronnyallan.net/2017/04/25/diagnosed-with-neuroendocrine-cancer-10-questions-to-ask-your-doctor/