Generic drugs Archives

Tag: 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.

12 Jan 2024

By Ronny Allan

1 Comment

US FDA Approves Radioequivalent Lu 177 Dotatate Product BRAVNETSA for GEP-NETs

TreatmentGastro-entero-pancreatic neuroendocrine tumour (GEP-NET), Generic drugs, Peptide receptor radionuclide therapy (PRRT), Radiolabelled somatostatin analogue, Somatostatin receptors (SSTR), SSTR-PET

Update 22 Sep 2026. US FDA approves the product. The FDA determined BRAVNETSA to be bioequivalent and therapeutically equivalent to LUTATHERA (lutetium Lu 177 dotatate), according to a press release statement. BRAVNETSA is indicated for treating GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors. BRAVNETSA was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway. As part of this review, BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, LUTATHERA.Click here to read the press release from Lantheus. Update 1st July 2026This approval was being held up by legal processes…

22 Apr 2021

By Ronny Allan

10 Comments

Generic Somatostatin Analogues for Neuroendocrine Cancer

TreatmentBynfezia Pen, Generic drugs, Lanreotide, Octreo-ratiopharm®, Octreotide, Olatuton®, Sandostatin, Somatostatin analogues, Somatostatin receptors (SSTR), Somatuline Autogel (US: depot)

Generic Somatostatin Analogues. I've covered a lot about somatostatin analogues, particularly the two predominant approved drugs Lanreotide and Octreotide. Octreotide has many particularly in daily shots and more recently in long acting, but Lanreotide being a newer drug has taken a while for generics to appear. I had to study what generic means and it's important to differentiated the brand from the actual drug name as the latter does not normally change. 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…

04 Apr 2016

By Ronny Allan

3 Comments

Somatostatin Analogues and delivery methods in the pipeline

Awareness, Clinical Trials and Research, Living with Neuroendocrine CancerAcromegaly, Adrenocorticotropic Hormone (ACTH), Bynfezia Pen, COR-003, COR-005, Cortisol, CRN01941, Cushing's disease, Cushing's syndrome, DP1038, Everolimus, Flushing, Generic drugs, Growth hormone (GH), Hypercortisolism, Insulin-like growth factor 1 (IGF-1), Lanreotide, Levoketoconazole (Recorlev), MTD201, MYCAPSSA , Neuroendocrine cancer, Neuroendocrine tumour (NET), Octreotide, Octreotide-RP, Pasireotide, Q-Octreotide, RECORLEV (levoketoconazole), SIGNIFOR® (Pasireotide), SOM230, Somatoprim, Somatostatin receptors (SSTR)

NOTE - THIS IS IN NEED OF AN UPDATE AND IS ON MY LIST OF THINGS TO DOThis is my live blog post covering new developments in the area of new Somatostatin Analogues and new delivery systems. AbstractAs most of you will be aware, there are currently two main types of Somatostatin Analogues (SSA) in use for the treatment of mainstream Neuroendocrine Tumours (NETs) - Octreotide and Lanreotide. You can click on the links for information on both of these well-known NET treatments. This post will focus on the not so well known and anything in the pipeline including different delivery…