mAbxience | Blog

FDA PLAN TO ENCOURAGE BIOSIMILAR MEDICINAL PRODUCTS IN THE UNITED STATES

09/17/2018

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

08/13/2018

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

07/16/2018

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

03/23/2018

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

03/12/2018

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 […]

Biosimilar Use Position Paper Of Brazilian Society Of Clinical Oncology (SBOC)

02/19/2018

The Brazilian Society of Oncology has just published its position paper, which includes the most important points on the approval and use of biosimilar drugs in oncology. Also included are aspects relating to their definition, nomenclature, extrapolation, interchangeability, automatic substitution, safety, efficacy and potential impact on healthcare budgets. The Society is in favour of introducing […]