Breyna, a generic version of Symbicort (budesonide-formoterol), is now available in the U.S. for eligible individuals with chronic obstructive pulmonary disease (COPD) and asthma. This inhaled medication, approved by the U.S. Food and Drug Administration (FDA), will be immediately accessible to eligible patients.
Similar to Symbicort, Breyna is approved as a maintenance therapy to reduce airflow obstruction and prevent exacerbations in people with COPD, as well as in asthma patients aged 6 and older. It is not intended for use as an on-demand treatment for acute asthma or COPD attacks.
Mylan Pharmaceuticals, now part of Viatris, developed Breyna. The U.S. launch of the generic version is being conducted in collaboration with Kindeva Drug Delivery, a specialist in drug-device combination products.
To enhance accessibility, the company has introduced a copay program for commercially-insured patients, which will be available this month. This program aims to reduce out-of-pocket costs for Breyna prescriptions to as low as $20 for a 30-day supply. It costs $30 per month for 12 refills annually, resulting in savings of up to $360 per year.
Symbicort, developed by AstraZeneca, is one of the most commonly prescribed complex drug-device combination products for treating asthma and COPD. It combines budesonide, an inhaled corticosteroid that reduces inflammation and swelling, with formoterol, a long-acting bronchodilator that relaxes airway muscles, making breathing easier. The medication combination is inhaled directly into the airways using a metered-dose inhalation device.
Generic versions of therapies are expected to have the same active ingredient, strength, route of delivery, safety, efficacy, and intended use as their brand-name counterparts. However, they are usually available at a significantly lower cost.
To establish Breyna as a generic substitute for Symbicort, Viatris had to submit an abbreviated new drug application (ANDA) to regulatory authorities. These applications typically do not require specific clinical trials showing efficacy and safety but must demonstrate bioequivalence, meaning that the generic is expected to work in the same way as the brand-name reference.
Breyna comes in two dosage strengths, containing either 80 or 160 micrograms (mcg) of budesonide, with both formulations having 4.5 mcg of formoterol. The higher dose is approved only for COPD patients and must be taken as two inhalations twice daily.
The most common side effects of Breyna in COPD patients include cold-like symptoms, oral candidiasis (a fungal infection), airway inflammation, inflamed sinuses, and upper respiratory tract infections.
– Breyna: [Homepage]www.viatris.com/
– Mylan Pharmaceuticals: [Homepage]www.viatris.com/
– Viatris: [Homepage]www.viatris.com/
– Kindeva Drug Delivery: [Homepage]www.kindeva.com/
– AstraZeneca: [Homepage]www.astrazeneca.com/