Hikma’s Advair generic delayed in the US

pharmafile | March 12, 2018 | News story | Sales and Marketing Advair, FDA, GSK, GlaxoSmithKline, pharma 

Hikma Pharmaceuticals has been knocked back with the news that the FDA has delayed approval of its generic lung treatment for lack of data, it has emerged, which is good news for GlaxoSmithKline, manufacturer of the reference product Advair, who will be able to avoid increased competition in the space for a little while longer.

The US regulator said that more data which would better demonstrate the drug’s non-inferiority to Advair was needed before it can hit the market. Hikma confirmed it now plans to gather additional data and resubmit its application in 2019, which would mean the product could potentially launch in 2020, the firm’s partner Vectura said.  

This is not the first time Hikma has had its plans for the drug frustrated by the FDA; the company was required to conduct another endpoint study by the US regulator in order to gather additional data. While the Jordan-based firm disputed the decision, the agency stood by it.

Mylan and Novartis’s Sandoz have also recently seen their own generic versions of Advair delayed in the US. While this is beneficial for GSK, analysts predict that the firm will see increased competition in the space as early as mid-2018.

Matt Fellows

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