Updated 18th December 2021
News just in….. the first generic version of Somatuline Depot (Lanreotide) in the US has been approved for marketing by the US FDA according to a press release from the company Cipla. This can often lead to price reductions, but I have no details other than what I published in my generic somatostatin analogues blog post attached.
The active ingredient, route of administration and strengths are the same as SOMATULINE DEPOT®, from Ipsen Biopharmaceuticals Inc.
See the Lanreotide section below.
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.
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 23 Jul 2021
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.
27 Jan 2022. A patient from Denmark informed me that Denmark now has a generic Lanreotide. The same name as the one announced below for Norway – MRYELEZ. According to this patient’s doctor, it is a third of the price.
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. “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.” Read more here.
There are plans to eventually distribute to the rest of Europe. Read more here
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.
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