European approval for fluticasone/salmeterol and gefitinib generics

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Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic fluticasone/salmeterol dry powder inhaler (DPI).

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Fluticasone/salmeterol is an inhaled drug used to treat asthma and chronic obstructive pulmonary disease (COPD).

Glenmark’s product, which will be called Salflutin (fluticasone/salmeterol) in Germany, is a generic version of GlaxoSmithKline’s (GSK) asthma inhaler Seretide/Advair Accuhaler (fluticasone/salmeterol). It will be the company’s first inhalation product available in Germany. A fact that it says ‘validates Glenmark’s capabilities in the complex inhaled respiratory products segment’.

Glenmark entered into a strategic development and licensing agreement with Celon Pharma in 2015 to develop and market generic fluticasone/salmeterol DPI in 15 European countries.

The company has already launched this product in Denmark, Sweden and Norway. According to IQVIA data, fluticasone/ salmeterol DPI had sales of US$844 million in Europe in the 12-month period ended March 2018.

US generics manufacturer Mylan launched the first bioequivalent alternative to GSK’s Seretide/Advair Accuhaler in the UK back in June 2015 [1].

Generic gefitinib tablets have been approved in Europe and a generic fluticasone/salmeterol dry powder inhaler has been approved in Germany.

US generics company Alvogen announced on 5 September 2018 that it had successfully concluded multiple registration applications for generic gefitinib tablets.

Gefitinib is a drug used to treat certain breast, lung and other cancers. The originator product, AstraZeneca’s Iressa (gefitinib), had global sales of US$528 million and European sales of US$136 million in 2017.

Alvogen’s gefitinib is a fully generic and bioequivalent version of Iressa tablets and has been fully developed in-house. The drug is indicated for non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK). Gefitinib was developed by Lotus Pharmaceuticals, an Alvogen affiliate. Marketing authorizations have been filed by Alvogen and its partners in 24 European countries.

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1.  GaBI Online - Generics and Biosimilars Initiative. Mylan launches generic asthma inhaler in UK []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from:

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Source: Alvogen, Astrazeneca, Glenmark

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