In an example of the innovative nature of generics manufacturers, Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 12 February 2014 that it had received marketing authorization in Belgium for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).
AirFluSal Forspiro, which is a generic of GlaxoSmithKline’s (GSK’s) Advair (fluticasone/salmeterol), was first approved in Denmark on 18 December 2013 [1] with subsequent marketing authorizations received in Bulgaria, Germany, Hungary, Norway, Romania and Sweden.
AirFluSal Forspiro offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device. Belgium has approved the high strength dosage form (50/500 µg) for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD.
One problem with producing generic inhalers is that in the US the regulatory process is unclear and there are no published guidelines for substitutable generic inhalers. In Europe the guidelines exist, but the bioequivalence requirements are so stringent that it has been said that ‘not even different batches from one of the originators would fulfil these requirements’. It is therefore a major achievement for Sandoz that they have gained approval for this product following European Union (EU) decentralized procedures (DCP) for eight EU countries, including Belgium.
Inhalers are expected to represent a significant opportunity for generics companies in the coming years, with US$19 billion losing their patent protection by 2018. However, product development is complicated by the drug delivery platforms, which have an average of 10 patents per device. Thus in Sandoz’s case, developing an innovative device is a major result for the company, allowing it to bypass GSK’s patent on its delivery device (Diskus), which remains in force until 2016 [2]. Patents on Advair expired in 2010 and 2013 for the US and Europe, respectively.
Commercial costs for generic respiratory products are expected to be even higher than for biologicals due to the levels of promotional spending by originator companies. However, the sector still represents a major opportunity for generics manufacturers. Advair is the world’s third-best selling drug with revenue of £5 billion (US$8 billion) during 2012.
Sandoz is also not the only generics maker to see an opportunity in this market, generics giant Teva Pharmaceutical Industries has also said that it will focus drug development efforts on respiratory illnesses [3].
References
1. GaBI Online - Generics and Biosimilars Initiative. Sandoz gains Danish approval for innovative asthma inhaler [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 14]. Available from: www.gabionline.net/Generics/News/Sandoz-gains-Danish-approval-for-innovative-asthma-inhaler
2. 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 Feb 14]. Available from: www.gabionline.net/Generics/News/Advair-could-face-competition-from-generics-as-early-as-2016
3. GaBI Online - Generics and Biosimilars Initiative. Teva cost-cutting and re-organization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 14]. Available from: www.gabionline.net/Pharma-News/Teva-cost-cutting-and-re-organization
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