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Mabxience achieves European accreditation for a bio medicine against cancer

The European Commission has just authorized a biosimilar medicine for the treatment of various cancers that the Insud Pharma company is already making at its Mabxience plant, in the León Technology Park. The validation opens the doors for the drug to be marketed in Europe and used in the hospitals of the countries that comprise it. The company in Madrid explains that the efficacy of MB02 — the name of the drug — has already been demonstrated for the treatment of colon or rectal carcinoma, breast cancer, some types of lung cancer, renal cell cancer, epithelial ovarian cancer , fallopian tube or primary peritoneal and carcinoma of the cervix.

Insud Pharma has three plants in León. In addition to Mabxience, León Farma and Farmalam, dedicated to hormonal drugs and hormonal injectables, respectively, both focused on treatments for women. Mabxience is specialized in the production of biosimilars, medicines that, compared to traditional ones, developed in a process of chemical synthesis, contain one or more active ingredients produced or derived from a biological source. The organic medicines developed in the Leon plant are used mainly in hospitals, for the treatment of autoimmune or oncological diseases.

Oncology
The biosimilar is indicated for the treatment of colon, lung, breast or cervical cancer.

Bevacizumab is the Avastin brand biosimilar drug developed by Mabxience that will be marketed under the names Alymsys and Oyavas. In other words, the process approved by the European Commission allows the manufacture of a composition of the original drug – whose patent has already expired – in order to make it more accessible to a greater number of patients. It would be, as with traditional medicines, a generic or biosimilar, in this case, another already developed by a brand.

Moment of change

With the backing of Europe, Mabxience enters the European market for biosimilars for the treatment of some cancers, since after passing the procedure – which guarantees that the drug developed in León is highly similar to the reference medicine and its data shows a quality , comparable safety and efficacy— it can be used in all hospitals of the countries that make up the European Union.

From the company —which brings together the development, manufacture and commercialization of medicines— the CEO of Mabxience, Emmanuelle Lepine, specifies that “we are witnessing a moment of vital importance throughout the world with our eyes and attention focused on the health systems and their sustainability. The launch of our Bevacizumab in the European market will be the perfect example of how innovation and the cutting edge in R&D technologies are the key to obtaining high-quality and accessible medicines that, in addition to providing alternatives to the health system, allow increasing the patient access to high-cost treatments. ‘

European Comission
The new product is more accessible than the original compound and its results are supported

Insud Pharma is one of the pillars of the pharmaceutical pole of León – which currently employs more than 1,500 workers – and which also provides the conditioner of bio. In addition to the three plants in the Leonese capital, it has another three in Spain. In August last year, the company signed an agreement with Astra Zeneca to manufacture the covid vaccine in Argentina and, in addition, in January of this year, another to manufacture the vaccine vials that is carried out in Guadalajara, where proceeds to its filling and packaging. An approach that, for the moment, the company rules out carrying out in León.

The Mabxience León plant was inaugurated in 2015 and has highly qualified profiles from all over the world. The company highlights that it is a young, dynamic and multidisciplinary team specialized in R&D, monoclonal antibodies and the biotechnology industry.

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