First Russian omalizumab biosimilar registered for the treatment of severe bronchial asthma

Bronchial asthma is a chronic disease of the respiratory tract, the key element of which is a narrowing of the bronchi lumen caused by specific immunological or nonspecific mechanisms, manifested by repeated episodes of wheezing, shortness of breath, asthma attacks, feeling of tightness in the chest and coughing.

The World Health Organisation (WHO) estimates that asthma affects about 339 million people worldwide. One of the most effective and well-tried treatment options for moderate to severe persistent atopic bronchial asthma is the omalizumab regimen described in numerous studies.

GENERIUM became the first Russian company that has managed to synthesise a recombinant humanised monoclonal antibody (mAb) to IgE, which will ensure the country's sovereignty in the manufacture of modern drug product, save the state budget funds and guarantee the protection of the Russian patient's rights to access the most modern therapy products.

'Omalizumab belongs to the group of monoclonal antibodies (mAbs) targeted to the regulation of immunoglobulin E, which play an important pathogenetic role in allergic reactions. I was among the first scientists in the world who began to use omalizumab in patients with severe forms of bronchial asthma. My long-term experience shows that this is an extremely effective agent. And the fact that the first Russian omalizumab has now appeared is a positive phenomenon that should be welcomed, and it will have a qualitative impact on the health of our patients', emphasised Alexander Chuchalin, member of the Russian Academy of Sciences, Head of the Therapy Department, N.I. Pirogov Russian National Research Medical University, Board Chairman of the Interregional Public Organisation Association the Russian Respiratory Society.

'Biological therapy aimed at the pathogenetic mechanisms of allergic diseases has become one of the major breakthroughs in clinical immunology. WHO identified allergic diseases as the dominant class requiring global studies and significant prevention efforts in the 21st century, as they consume significant resources of the health system. Omalizumab has become the world's first biologic medicinal product for the treatment of uncontrolled severe bronchial asthma. By Genolair release, GENERIUM implements a strategy of a full-cycle manufacture (from a cell bank to a finished dosage form) of medicinal products aimed at combating the main causes of disability and mortality among Russian citizens, which include infectious, cardiovascular and respiratory diseases', said Dmitry Kudlay, General Director, Generium JSC.

GENERIUM develops its medicinal products at the manufacturing site in the Vladimir region, which includes a modern production facilities and its own R&D park. The funds received from project implementation will be used for the development of national biopharmaceuticals and will supplement the country's tax revenues.