Coughing and sputtering, Hikma’s Advair generic comes back to life

As of yesterday Hikma is back in business with its generic version of Glaxosmithkline’s asthma and COPD drug Advair. The group said its version, formerly called VR315 and derived from a deal with Vectura, was being relaunched in the US after a long hiatus; this had involved a complete response letter back in 2017, an unsuccessful appeal, a second CRL last September, approval and launch at last in December 2020, and then a surprising halt to the rollout the following month. The halt had been prompted by Hikma changing its filing to reflect enhanced packaging controls, but apparently that amended ANDA has now been approved. Assuming no further hiccups attention will turn to how big a drug Hikma’s generic could become; Evaluate Pharma sellside consensus forecasts 2026 revenues of $164m, but Stifel analysts reckon capturing 20% share of a US market that in 2020 was worth $3bn is possible within two years. At present the only other generic competitors to Glaxo’s Advair, which Stifel says has 49% market share, are Viatris (31%) and Prasco (authorised generic, 20%). Teva’s version is not substitutable, while Cipla’s generic was filed last May but is not expected to be approved before 2022.