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Newsletter 3

"UN CONGRESO PARA LOS PROFESIONALES
DE LA INDUSTRIA FARMACÉUTICA"

Dra. Dolores Querol.
Scientific Commitee


INTERVIEW WITH
DR. GONZALO CALVO

Speaker at BIOSIMILARS, REGULATION AND RULES' expert panel


Dr. Gonzalo Calvo

At the Congress, this topic is having certain impact. What are biosimilars?
Biosimilar is a concept similar to generic drugs, but applied to biological medicines. Given that they are generally complex molecules and have a difficult characterization, it's hard to guarantee structural identity with the innovative medicine. So, different from the generics' case, clinical and toxicological data are required to guarantee a similar security and effectiveness level than the reference product.

They are not well known yet, why?
Biosimilar medicines have a short trajectory. Every time there are more of them appearing on the market, although the penetration at the different European countries is very variable.

Which is the panel of expert's target?
It is addressed to three professional profiles: pharmaceutical industry (as an active/pasive agent of biosimilars' products); medicines' regulations professionals; and managers and decision makers, among others.

How is biosimilar's situation in Spain compared to other European countries?
Its penetration's rate in Spain is low compared to other European countries, and the potential scope is very high yet. Many of the approved bisosimilars are not even commercialized in our country. A greater knowledge and maybe a Spanish biosimilars' industry could contribute to a greater penetration.

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