mAbxience | Blog

Biological and biosimilar medicinal products and real world evidence

When a pharmaceutical company develops a new medicinal product, it conducts a series of studies to demonstrate the efficacy and safety of the medicine in certain diseases. These are called clinical trials1 and they are submitted to the regulatory authorities when applying for marketing authorisation for the medicinal product. They are a powerful tool demonstrating […]

How do monoclonal antibodies work against cancer?

In 1997, rituximab, the first monoclonal antibody indicated for oncological use, was launched for non-Hodgkin lymphoma (also used in rheumatoid arthritis and leukaemia, among others)1. This marked the start of the era of so-called targeted therapies for cancer treatment2. There are currently 27 monoclonal antibodies approved for use in different types of cancer, which represents […]

Development of biosimilars in Europe and the United States in 2018

The history of biosimilars in Europe began with the approval of the somatotropin biosimilar (growth hormone) in 2006, thus becoming a pioneer in the incorporation of these drugs into clinical practice. Since then and to date, 53 biosimilars of 18 different active substances have been approved1. For its part, the United States did not give […]

The imminent wave of biosimilars in oncology
(Extracted from ESMO Open Cancer Horizon, September 20181)

Since 2001, 59 biosimilars have been submitted for approval in Europe, of which 39 (25 different molecules) have been approved and marketed. In 2017 alone, 14 biosimilars were approved, including the first biosimilar for use in oncology. The list of biosimilars in oncology is growing rapidly: 6 rituximab biosimilars have been approved, 1  bevacizumab and […]

Recent publication in the The Lancet Gastroenterology and Hepatology on the mAbxience bevacizumab biosimilar(BEVZ92)1

The results of a clinical trial comparing the bevacizumab biosimilar BEVZ92 versus the original bevacizumab as the reference product, in combination with chemotherapy, in patients receiving first-line treatment for metastatic colorectal cancer were recently published in the prestigious journal, The Lancet Gastroenterology and Hepatology. We give an overview of the most important data from the […]

Monoclonal antibody production

In 1975, Milstein and Köhler discovered monoclonal antibodies1 (see article: “What is a monoclonal antibody?”), starting a revolution in the diagnosis and treatment of many diseases1. Their widespread availability has been made possible thanks to the development of manufacturing processes using cell cultures2,3. 1. Attainment in the laboratory The industrial production of monoclonal antibodies starts in […]