Blog mAbxience


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 [...]


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 [...]


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 [...]


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. [...]


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 [...]


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 [...]


Biosimilar medicines: access to clinical practice


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


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


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


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 [...]


Progression in the medium to long-term


As we have been outlining so far in previous posts, three trends are anticipated in the medium to long-term in the progression of biosimilar drugs. These include [...]


The industry’s commitment: a long-distance race


Introducing biosimilars onto the market is a very slow, expensive and risky process. Besides having to wait for the original drug or reference drug patents to expire, [...]


Economic impact according to experts


As we have already mentioned in previous posts, several international consultants have conducted studies estimating the economic saving that biosimilars could generate for the Spanish national health [...]


Allies of the national healthcare system


As we have already mentioned in previous posts, taking into account that the efficacy, safety and quality of biosimilar drugs are similar to that of their reference [...]


Entry barriers in healthcare systems


Before drugs go on sale, they have to pass a series of technical and administrative controls, which are regulated by the Food and Drug Administration (FDA) in [...]




Lymphoma is a malignant proliferation of lymphocytes that generally takes place in the lymph nodes, although other organs such as the liver, spleen or bone marrow may [...]


Contribution to healthcare expenditure and the government's response


Biologics are obtained through genetic engineering processes which are characterised by high costs. In addition, they are used to treat diseases which have a significant economic impact [...]


The savings potential of biosimilars


The last two content blocks allowed us to take a closer look at the real-life implication of biosimilars by offering insight into their social repercussions within the [...]


Biosimilars and their social repercussions and their accesibility


At a time when the burden of chronic disease is increasing throughout the world, it is more important than ever to improve the health of the general [...]


A commitment to help patients with autoimmune diseases


Autoimmune diseases represent a therapeutic area that, despite having lower incidences to that of cancer, often faces neglect. Such diseases affect 8% of the population with over [...]


The contribution of monoclonal antibodies in haematology


As we have said in previous posts on the social impact of biosimilars, we can now see that both the pharmaceutical industry and national health systems are [...]


Biosimilars provide support in the fight against cancer


Cancer features in all sector studies as one of the main causes of death around the world. In 2015, 227,000 new cancer cases were diagnosed in Spain, [...]


Biosimilars and their social repercussions


The key role of accessibility   The purpose of the second part of this blog is to investigate the social repercussions of biosimilars. This and upcoming posts will assess [...]


Biosimilar's manufacturing process


How is a biosimilar manufactured?   Along the lines of the previous post, in which we explained the steps leading to the development of a biosimilar, the aim of [...]


An examination of biosimilars and mAbs


The aim of this post is to explain how a biosimilar is developed. It has to be said that the process involves a certain amount of complexity [...]


A long history: An introduction to biosimilars and monoclonal antibodies (mAbs)


As we mentioned in the last post, biopharmaceuticals encompass all substances used to treat a disease that are solely and exclusively extracted from living creatures. The interesting [...]


What are mAbs biosimilars?


An introduction to biosimilars and monoclonal antibodies (mAbs)   The purpose of this second post is to provide a simplified yet accurate introduction to biosimilars.   The first thing to know [...]




mAbxience is more than aware that the biggest limitation for progress and innovation is lack of knowledge, which has a direct effect in the case of biosimilars. In view of this, the company strives to inform people and, more importantly, shed light on the entity, origin and evolution of biosimilars in society, so that they can be better understood.