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.
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 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 continues to supply via its 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, and 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.” Read more here.
There are plans to eventually distribute to other countries in Europe (tbc). Read more here.
The Injection Device
The injection device selected by Advanz Pharma for both MYRELEZ and MYTOLAC is based on the SAN-Light product from DALI.
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.
The SAN-Light enables an enhanced experience for patients and the people who administer the injections, whether they are healthcare professionals, family members, or patients. The automatically activated (passive) needle shield reduces needle-stick injuries, and the partially hidden needle alleviates needle anxiety. Additional design features further facilitate injections. Read more here
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 mentioned above (see pictures above).
First generic of Lanreotide for USA? A different route to approval called 505 (b)(2). Same principle though but quicker route to approval.
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.
Some of the new delivery systems in a 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. Breckenridge is a distributor for NatCo Pharma.
There are others – read here Generic Afinitor Availability – Drugs.com
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