1st approved Symbicort generic, Breyna, now available in US
New copay program for COPD patients aims to lower costs of therapy
Breyna, a generic version of Symbicort (budesonide-formoterol), has been launched in the U.S. for eligible people with chronic obstructive pulmonary disease (COPD) and asthma.
The inhaled medication — the first Symbicort generic to be approved by the U.S. Food and Drug Administration — will become immediately available to eligible patients.
Like Symbicort, Breyna is approved as a maintenance therapy to lower airflow obstruction and prevent exacerbations in people with COPD, and for asthma patients, ages 6 and older. The medications are not intended to be used as on-demand treatments for acute asthma or COPD attacks.
Breyna was developed by Mylan Pharmaceuticals, now a part of Viatris. The U.S. launch of the new generic is being done in partnership with the drug-device combination product specialist Kindeva Drug Delivery.
“We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD,” Jose Cotarelo, Viatris’ head of North America, said in a company press release.
Like Symbicort, generic Breyna is used as maintenance therapy
To further expand access, the company also has established a copay program for commercially-insured patients that will become available this month.
It’s intended to lower out-of-pocket costs for Breyna prescriptions to as little as $20 for a 30-day supply. The program costs $30 per month for 12 refills annually, a savings of up to $360 per year, according to the company.
AstraZeneca’s Symbicort is “one of the most prescribed complex drug-device combination products to treat asthma and COPD,” said Milton Boyer, CEO of Kindeva.
The therapy combines budesonide, an inhaled corticosteroid to reduce inflammation and swelling, and formoterol, a long-acting bronchodilator that relaxes airway muscles to make breathing easier. The medication combination is breathed directly into the airways through a metered-dose inhalation device.
A generic version of a therapy is expected to have the same active ingredient, strength, route of delivery, safety, efficacy, and intended use as its brand-name alternative. Yet, they usually come at a significantly lower cost.
For Breyna to earn its status as a Symbicort generic, Viatris had to submit an abbreviated new drug application (ANDA) to regulatory authorities.
“Being the first to bring an FDA-approved generic version of Symbicort to patients is a true example of how access is the cornerstone of our mission to empower people worldwide to live healthier at every stage of life,” Cotarelo said.
We are pleased for Viatris as well as the many Kindeva colleagues who have worked tirelessly … for this important respiratory product — supporting a persistent need to continue bringing more quality medicines for asthma and COPD to patients.
In general, these ANDA applications do not require clinical trials that explicitly demonstrate their efficacy and safety, but rather must show evidence that the generic is bioequivalent to its brand-name reference, meaning it has the same pharmacological properties and is expected to work exactly the same way.
As with Symbicort, Breyna comes in two dosage strengths containing 80 or 160 micrograms (mcg) of budesonide, both of which will have 4.5 mcg of formoterol. The higher dose is the only one approved for COPD patients. It should be taken as two inhalations twice daily.
The most common side effects of Breyna in COPD patients include cold-like symptoms, a fungal infection called oral candidiasis, airway inflammation, inflamed sinuses, and upper respiratory tract infections.
“We are pleased for Viatris as well as the many Kindeva colleagues who have worked tirelessly … for this important respiratory product — supporting a persistent need to continue bringing more quality medicines for asthma and COPD to patients,” Boyer said.
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