“The commercialization of the product would depend on national approval as well as substitution and pricing approvals,” the company said.
The product was registered under the decentralized process. The decentralized process is used when a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised approval by the EMA.
Glenmark had entered into a Strategic Development & Licensing Agreement with Celon Pharma S.A. to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product – Fluticasone / Salmeterol dry powder Inhaler in Europe.
“This is the first approval from the deal, and marks the entry of Glenmark in the Respiratory Generic segment,” it said.
This will also be Glenmark’s first inhaled Respiratory product approval in Europe, and re-enforces Glenmark’s commitment in the respiratory area, the company said.
The Fluticasone Salmeterol dry powder Inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease.
Seretide marketed by GlaxoSmithKline is among the top 3 pharmaceutical brands in Europe with sales of USD 1.1 billion as per IMS.
“Our successful registration closure of a complex respiratory product like Fluticasone Salmeterol Dry powder Inhaler (DPI) in a developed market re-enforces Glenmark’s capability and determination towards the respiratory segment. This continues to emphasize Glenmark’s focus in this complex product segment and in Europe.” said Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals Limited. H
“We will continue to work in the area of respiratory especially devices in Europe and we will continue to launch products in this area in future,” he added.