Curaxys is about to enter the European and international market offering an important updated portfolio of generics and biologic products.
A brief introduction
As soon as patents expire, biopharmaceuticals can be produced and marketed by manufacturers other than the originator. These new biotechnology medicines are known as “biosimilars” or “similar biological medicinal products” because they are claimed to be highly similar to an already approved reference product.
According to the European regulatory framework, biosimilarity means that the a biological product is highly similar to the licensed reference biological product, notwithstanding minor differences in clinically inactive components; and that there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.
In 2006, the first biosimilars have received European regulatory approval, therefore becoming a commercial reality in European markets.
Breast cancer is the most common cancer among women worldwide. Each year, 1.4 million new cases are diagnosed around the world, and over 450,000 people will die from the disease annually. One out of four affected women develops the so-called “HER2-positive” breast cancer, a very aggressive type of tumor that responds very poorly to chemotherapy.
Trastuzumab is a humanised monoclonal antibody, specifically designed to activate the body´s immune system and suppress the HER2 protein, to target and destroy the tumour. This increases the overall survival of patients, even in late-stage breast cancer.
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