Biosimilar products, the challenge of the XXI century

February 23, 2016

In recent decades, biotechnology has allowed the development of more than 650 biological innovative drugs to treat diseases like cancer and other serious diseases, such as haematological, neurological or endocrine illnesses. In the coming years a high percentage of drugs to be launched are going to be biological in order to satisfy the unmet treatment needs of many patients.

Biologic drugs are large molecules formed by proteins that are produced by living organisms. The production process of biologic drugs is more complicated than the chemical products because are manufactured by living organisms. This fact determines the characteristics and specific properties of these drugs. The cost of biological products is higher because all the investigation and the complicated manufacturing process.

Nowadays, there are approximately 250 biological medicines to treat 380 illnesses, but it is expected that in the coming years many patents of biological drugs will expire. Generic Pharmaceutical Companies like Galenicum will have the chance to commercialize biosimilar drugs.  These products are almost identical to the original, but the cell lines are different. Nevertheless, biosimilar products will have to ensure the efficacy and security.

The introduction of biological products is going to be under a solid regulatory framework, but in some countries the regulatory requirements are still not clear. Besides this, in some countries the regulatory requirements for chemical products is still a bit lax. For example, Antonio Luján, Managing Director of Galenicum Health Perú said in “El Comercio” that the Peruvian Medicines Agency hasn’t issued the regulations for the bioequivalence studies, which ensures the efficacy and safety of generic drugs.

 foto lupa resolució


Source: Spanish Bioindustry Association