mAbxience | Blog

Extrapolation of indications on biosimilars


The extrapolation of indications for a biosimilar consists in the regulatory approval of the biosimilar drug for the treatment of diseases that have not been specifically studied during the development of the same. Said approval is only possible if its biosimilarity has been demonstrated and if the mechanism of action is the same among the different indications pending […]

Differences between substitution and interchangeability


When a biosimilar drug is authorised by a regulatory agency, it means that it can be prescribed with guarantees over its efficacy and safety for all indications authorised in its summary of product characteristics. Therefore, a doctor may initiate treatment in a new patient with either the reference drug or a biosimilar. However, one of […]

How an audit of compliance with Good Manufacturing Practices (GMP) is processed


In light of the recent authorisation issued by the Spanish Agency for Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) for the mAbxience plant in León, we now explain how an audit is processed, drawing from the personal experience of the Quality Team at mAbxience León.   In order to obtain certification […]

Traceability and Pharmacovigilance


Biosimilars, like all biological drugs, undergo special vigilance for a 5-year period after they are approved. Drugs subject to this vigilance period are marked with a black triangle. In cooperation with the World Health Organization (WHO), the countries of the European Union have developed pharmacovigilance programmes for all biosimilars placed on the market so that health professionals may […]

Differences between biosimilars and generic drugs


One of the main problems that biosimilar drugs face is that many doctors and patients still cannot differentiate them from generic drugs, as they tend to believe both are simple copies of the original or reference drug. In fact, according to a survey created by the consultancy company PwC, 67% of consumers were not sure […]

Biosimilars’ economic predictions according to experts


The biological drugs market is rapidly growing, especially when compared to the chemical molecule drugs market. Proof of this lies in the fact that 9 out of 15 highest selling drugs in the last decade were biological, surpassing sales of one billion dollars during the course of the year. For example, the global sales of […]