Cipla's generic of GSK's Advair for asthma marks expansion into Europe

Indian generic drugmaker Cipla has entered the respiratory market in Germany and Sweden with its Serroflo (salmeterol/fluticasone MDI).

Serroflo is the generic version of UK pharma major GlaxoSmithKline (LSE: GSK)’s Advair, and aside from Croatia where salmeterol/fluticasone is already available as Duohal, will mark Cipla’s first entry into the European health care market.

Advair brought in sales of $8.25 billion in 2013, and Mylan has plans to file an application to the US Food and Drug Administration for its Advair generic in the third quarter of next year to begin selling in 2016. Even though the drug itself is out of patent, GlaxoSmithKline still has ownership of the dispensing inhalers, with the dispenser for the powder version expiring in 2016, and the aerosol in 2025. The FDA has issued guidance on the necessary characteristics for a generic device in order for it to not infringe on GlaxoSmithKline’s patent.