Extrapolation of indications on biosimilars

8 de May de 2017 por Admin Novigo

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 [...]


Differences between substitution and interchangeability

17 de March de 2017 por Admin Novigo

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 [...]


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

27 de February de 2017 por Admin Novigo

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 [...]


Traceability and Pharmacovigilance

6 de February de 2017 por Admin Novigo

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. [...]


Differences between biosimilars and generic drugs

20 de January de 2017 por Admin Novigo

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 [...]


Biosimilars’ economic predictions according to experts

16 de December de 2016 por Admin Novigo

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 [...]


Biosimilar medicines: access to clinical practice

7 de December de 2016 por Admin Novigo

On 3rd November, the Health Research Foundation (Fundación para la Investigación en Salud - FUINSA) held a conference in Madrid to address the access of biosimilar medicines to clinical practice. Representatives from [...]


World Biosimilar Congress Europe 2016

28 de November de 2016 por Admin Novigo

On 14th and 15th November 2016 the 5th World Biosimilar Congress was held in Basel (Switzerland). It addressed subjects like the pre-clinical and clinical development of biosimilars, the extrapolation of indications and interchangeability, [...]


Outlook on biosimilars

18 de November de 2016 por Admin Novigo

There is no doubt that biological drugs are the treatment future for many pathologies. They can be used in areas such as oncology, diabetes or pain control. However, they are much more [...]


Influencing factors in the implementation of biosimilars

4 de November de 2016 por Admin Novigo

A study conducted by the consultancy company GFK on behalf of the European Biosimilars Group analysed the main factors that support a sustainable European biosimilar drugs market [...]