- ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals.
- Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology.
- This biosimilar is the third bevacizumab to be licenced in the United States.
Brand Institute is pleased to announce its successful collaboration with Amneal Pharmaceuticals in the development of the ALYMSYS® brand, which will be used to sell the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022. This biosimilar is the third bevacizumab to be licenced in the United States.
ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology.
Alymsys is a ‘Biosimilar medicine “. This means that Alymsys is highly similar to another Biological Medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Alymsys is Avastin.
Active Pharmaceutical Ingredient : Bevacizumab.
- Bevacizumab is a full-length IgG1κ isotype antibody composed of two identical light chains (214 amino acid residues) and two heavy chains (453 residues) with a total molecular weight of 149 kDa.
- Bevacizumab injection products are in a class of medications called antiangiogenic agents.
- They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.
Medical Use :
Alymsys is a cancer medicine that is used to treat adults with the following cancers:
- cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
- breast cancer that has spread to other parts of the body;
- a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Alymsys can be used in non-small cell lung cancer unless the cancer originates in cells called squamous cells;
- cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
- cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb, and the peritoneum, the membrane that lines the abdomen) that is advanced or has come back after treatment;
- cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or has spread to other parts of the body.
Mechanism of Action :
Bevacizumab acts by selectively binding circulating VEGF, thereby inhibiting the binding of VEGF to its cell surface receptors. This inhibition leads to a reduction in microvascular growth of tumor blood vessels and thus limits the blood supply to tumor tissues.
The API in Alymsys, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes new blood vessels grow. By attaching to VEGF, Alymsys stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours
“The entire Brand Institute and Drug Safety Institute Team congratulates Amneal Pharmaceuticals and mAbxience on the FDA approval of ALYMSYS,” said Brand Institute’s Chairman and C.E.O., James L. Dettore.