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.

Advair and its generics
Company US status Note Global 2021e sales
Glaxosmithkline Available since 2001 Original brand $1,745m
Teva Airduo Respiclick approved Jan 2017 Not substitutable $46m
Viatris Wixela Inhub approved Jan 2019, after Mar 2017 CRL Substitutable $884m
Prasco Laboratories Launched Feb 2019 Authorised generic NA
Hikma/Vectura CRL May 2017; CRL Sep 2020; approved Dec 2020; halted Jan 2021; approved Apr 2021 Substitutable $141m
Cipla Filed May 2020 US approval not expected before 2022 $56m
Sandoz (Novartis) Discontinued after Feb 2018 CRL Had been aiming to refile in 2019 None
Source: company releases & Evaluate Pharma.

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