Generic Somatostatin Analogues for Neuroendocrine Cancer

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I’ve covered a lot about somatostatin analogues, particularly the two predominant approved drugs Lanreotide and Octreotide.  Recently I read about generic drugs and found there are some for octreotide and as at Jul 2021, at least one for Lanreotide.  I was concerned to hear a patient asking a question about generic drugs in my private Facebook group with the main concern being they could be of lesser quality.  I studied that in more detail and here are the results of my research. 

What are generic drugs?

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.  You can buy many “branded” versions of paracetamol in UK, similar to 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. 

4.  Generic drugs tend to be cheaper because applicants do not have to repeat animal and clinical (human) studies 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 forces the original patent holder to reduce their own prices.

What are the generic somatostatin analogues for Octreotide?

As at  30 Aug 2022

There have been several Octreotide generics for some time.  Examples of given below.   Patients should contact me if I need to add others to the list – this will help other patients who become concerned by the different naming.

  • TEVA.  TEVA is a global pharmaceutical company with headquarters in Israel. It specializes primarily in generic drugs including octreotide long acting.  It is branded as “Octreotide (Olatuton®)“.  Appears to be in use in UK according to patient feedback but I can see EU and US approvals (more here).  Read about Olatuton® in the UK here.
  • 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.
  • 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 long and 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 continue to supply via their own brands. 

What are the generic somatostatin analogues for Lanreotide?

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 USA below. 

As at  30 Aug 2022

August 2022.
Advanz Pharma confirmed to me:

Mytolac
is the brand name in Germany and Netherlands. 

Myrelez 
is the brand name in Denmark, Finland, Norway, France, Spain. 

First deployments of both brands in Europe:

Announced 12 November 2021. 
Advanz Pharma announces the launch of MYRELEZ in Norway, the first generic lanreotide for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs).”  Read more here

Announced 21 July 2021. 
Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany for the treatment of acromegaly, grade 1 and a subset of grade 2 gastroenteropancreatic neuroendocrine tumors and symptoms associated with neuroendocrine tumors.” Readmore here

There are plans to eventually distribute to other countries in Europe (tbc).  Read more here

The picture below is MYTOLAC, assuming MYRELEZ is a similar delivery system

Picture Credit: Yone (NET Patient) from Netherlands

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.  

First generic of Lanreotide for USA?  A different route to approval called 505 (b)(2).  Same principle though but quicker route to approval. 

Click to visit the Cipla Lanreotide website

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. 

Read more here

Clinical Trials

Some of the new delivery systems in clinical trial will clearly be using generic brands if their product is authorised for marketing. Read more about some of these octreotide-based products here

Other generics for NET? 

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

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Thanks for reading.

Ronny

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Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

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9 thoughts on “Generic Somatostatin Analogues for Neuroendocrine Cancer

  • 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.

  • Sowdhamini Chandrasekhar

    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!

  • LINDA j HICKAM

    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?

      • Linda

        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!

  • John Parkes

    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

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