Sandoz gains Danish approval for innovative asthma inhaler

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Sandoz gains Danish approval for innovative asthma inhaler

Generics/News | Posted 10/01/2014 0 Post your comment

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).

The AirFluSal Forspiro inhaler device features an innovative, patient-friendly design, including multiple feedback mechanisms, such as visual control features which helps reassure the patient about dosing; simple lever arm to load the dose; and clear and accurate dose counter.

Sandoz’s AirFluSal Forspiro combines salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative new inhalation device. The product is a generic of GlaxoSmithKline’s (GSK’s) Advair (fluticasone/salmeterol). Advair, which delivers two drugs to patients orally through an inhaler, is the world’s third best-selling drug with revenue of GBP 5 billion (US$8 billion) during 2012 and accounts for about a fifth of GSK’s annual sales.

The European patent on Advair expired in 2013. In the US the patent expired in 2010, but a separate patent on the delivery device (Diskus) remains in force until 2016 [1].

GSK had argued that the same drug in a different inhaler was a different product because the device used to administer the medicine can cause dosing to vary. However, the Danish approval opens the door for Advair generics. Generics companies, including Actavis, Cipla, Mylan, Sandoz, Teva Pharmaceutical Industries and Vectura are all thought to be working on generic versions of the blockbuster asthma drug.

Denmark has approved both mid- and high-strength dosage forms (50–250 µg and 50–500 µg) for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The Danish approval follows the completion of EU decentralized procedures (DCP) for eight EU countries, including Denmark.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Advair could face competition from generics as early as 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Generics/News/Advair-could-face-competition-from-generics-as-early-as-2016

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Source: Sandoz