First Dual Bronchodilator Made in Russia for COPD Patients
The first domestically-produced dual bronchodilator – a combination of glycopyrronium bromide and indacaterol – is now available for patients with chronic obstructive pulmonary disease (COPD) through reimbursement programs and pharmacies across the country.
The dual bronchodilator for long-term maintenance therapy of bronchial obstruction in adults aged 18 and older with COPD is marketed under the trade name Respihale® and manufactured by the Russian biopharmaceutical company PSK Pharma at its modern GMP-compliant facility in the Dubna Special Economic Zone.
As of 2024, 2.4 million people in Russia have been diagnosed with COPD, however according to the Russian Respiratory Society the condition affects up to 11 million patients, including undiagnosed cases. COPD ranks first among causes of death from respiratory diseases in the country.
In recent years, a substantial body of evidence has accumulated regarding the use of the LABA/LAMA combination, specifically glycopyrronium bromide + indacaterol, showing its efficacy and reduced risk of side effects compared to increasing the dose of single bronchodilators. According to Russian statistics, dual bronchodilators are prescribed to six out of ten COPD patients.
Oksana Krasnykh, Head of the Retail Sales Business Unit at PSK Pharma commented: "We proudly call ourselves experts in pulmonology because today PSK Pharma is the only pharmaceutical company in Russia producing the full range of respiratory products for asthma and COPD treatment. All of our generic inhalation drugs undergo clinical trials, including testing on next-generation impactor (NGI) devices that evaluate the distribution of the active ingredient in the lungs. This is how we can claim proven quality, efficacy, and safety — not just on paper, but in practice. Unlike asthma patients receiving free medications under reimbursement programs, COPD patients are only eligible for free treatment if they have confirmed disability status. COPD treatments tend to be expensive, so we're proud to offer more affordable yet equally effective medications thanks to localized production for our fellow Russians. The first domestic dual bronchodilator Respihale® is already available both in public and retail segments."
Respihale®, manufactured by Russian biopharmaceutical company PSK Pharma, was officially introduced on the medical community last week at a Satellite Symposium during the Third National Congress with International Participation "Pulmonology of the 21st Century" chaired by Professor Sergey Nikolaevich Avdeev, MD, Academician of the Russian Academy of Sciences, and Chief Freelance Pulmonologist of the Ministry of Health of Russia.
Respihale® demonstrates comparable efficacy and safety, therapeutic and bioequivalence, when compared to the reference drug. It is supplied in the form of a single-dose dry powder inhaler.
Speaking at the symposium during the congress, Professor Sergey Avdeyev highlighted the relevance of dual approaches in COPD treatment: "Today, we employ a wide variety of medications for COPD therapy, including mono-, dual, and triple therapies. However, inhaled corticosteroids (ICS) are not suitable for everyone. When considering large patient populations without personalized stratification — based on exacerbations, eosinophil levels, and the increasingly important - dual combinations have proven to be both effective and widely used."
In his presentation, Professor Zaurbek Ramazanovich Aisanov, MD, stated: "Currently, fixed dual combinations combinations represent a modern and basic solution for pulmonologists in the treatment of COPD. The emergence of the first domestic dual bronchodilator will ensure access to modern medications for COPD treatment in Russia and reduce the risks associated with changing external conditions. Thus, it's good news both for us, the physicians, and for patients."
Professor Aleksandr Igorevich Sinopalnikov, Head of the Department of Pulmonology of the Russian Medical Academy of Continuing Professional Education, explained when dual bronchodilators are used: "Long-acting bronchodilators are the cornerstone of modern COPD therapy. The key criteria for switching from monotherapy to dual therapy include persistent symptoms despite the use of long-acting β₂-agonists (LABAs) or long-acting antimuscarinics (LAMAs), severe disease symptoms, and history of exacerbations."
PSK Pharma’s portfolio already includes 25 pulmonology drugs, five of which were the first to be reproduced in. Another eight drugs are at various stages of development. The company continues to actively expand its respiratory line, providing medications for asthma and COPD in various forms (MDIs, DPIs, and inhalation solutions) that serve as the gold standard in respiratory disease treatment.