mAbxience | Blog
WHAT IS A MONOCLONAL ANTIBODY?
Since 1986, when muromonab-CD3 was approved for the prevention of organ transplant rejection, monoclonal antibodies are being increasingly used. Nowadays there are a lot of these medicines approved, in Europe and United States, for the tretament of complex diseases such as rheumatoid arthritis, multiple sclerosis or cancer, and monoclonal antibodies biosimilars of some of them are […]
FDA PLAN TO ENCOURAGE BIOSIMILAR MEDICINAL PRODUCTS IN THE UNITED STATES
In 1984, the United States approved the Hatch Waxman Act to boost competition among generic medicinal products. These now comprise 90% of prescriptions across the country, generating savings for the healthcare system of 1 trillion dollars. In 2017 alone, the savings amounted to 265 billion dollars1. Biological medicinal products represent almost 40% of total spending […]
Experience accumulated in switching from reference biological medicinal products to their biosimilars: meta-analysis of more than 14,000 patients
Biological medicinal products contain active substances obtained from a biological source, such as live organisms or cells1. Biosimilars are medicinal products that are highly similar to already-marketed biological medicinal products, manufactured by different companies, using independently-developed cell lines and the companies’ own manufacturing processes.2 Although strict controls are put in place during manufacturing to ensure that minor […]
The role of biosimilar medicines in cancer
The introduction of biological therapies1 has led to major advances in cancer treatment in the last 20 years. These drugs are specifically intended for particular targets that are found in some types of tumours, and they have led to a radical change in the disease’s prognosis.2 Research and production costs for these drugs are very high, as […]
The 2nd Spanish Biosimilars Conference organised by BIOSIM
The 2nd Spanish Biosimilars Conference organised by BioSim, the Spanish Association of Biosimilars, took place in Madrid on 21st February at the headquarters of the Ministry of Health, Social Services and Equality. This second conference of its kind brought together several important ministry subdivisions, medical and patient associations, healthcare professionals, specialised communication media and representatives […]
Innovator-Biosimilar Interchangeability: Safety And Efficacy Data In Clinical Practice
Interchangeability is the medical practice consisting of changing a medicinal product for another that is expected to obtain the same clinical effect in a particular clinical picture, and in any patient, at the discretion of the prescribing doctor. (1) It is therefore possible to exchange one biological medicinal product for another, as long as the […]