Hikma launches generic Advair Diskus following FDA nod

Sandra Levy
Senior Editor
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Vectura's partner Hikma has launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder), in dosage strengths of 100mcg/50mcg and 250mcg/50mcg doses.

Hikma’s fluticasone propionate and salmeterol inhalation powder is indicated for the treatment of asthma, the maintenance treatment of airflow obstruction, and for reducing exacerbations in patients with chronic obstructive pulmonary disease. It is delivered using Vectura’s proprietary lever-operated multi-dose inhaler device technology.

“This is excellent news for Vectura and for people living with asthma and COPD in the United States. Approval of this high quality substitutable generic product for Advair Diskus validates Vectura’s rare, industry-leading development capabilities and the strong partnership we have with Hikma," said Will Downie, CEO of Vectura. "Approval of this product paves the way for our substitutable drug-device combination program, also partnered with Hikma, for generic versions of the GSK Ellipta portfolio, in the coming years.”

“The approval of our generic version of Advair Diskus marks an important milestone in our strategy to develop more complex respiratory products," Siggi Olafsson, Hikma CEO said. "Through the unwavering dedication of our employees and close collaboration with the Vectura team, we have developed a high quality and substitutable generic product for Advair Diskus that will improve availability of this critical medicine. We are very pleased to have now launched this product and will leverage the investments we have made and the experience we have gained through this process to develop a range of respiratory and other complex treatment options for patients and healthcare providers, helping us to continue to put better health, within reach, every day.”

Fluticasone propionate and salmeterol inhalation powder 100mcg/50mcg and 250mcg/50mcg, have a market value of approximately $2 billion in the 12 months ending September 2020, according to IQVIA.