- Generic drugmaker Hikma Pharmaceuticals said Thursday the Food and Drug Administration had rejected its copy of GlaxoSmithKline's flagship asthma drug Advair, likely meaning the British drugmaker won't face competition to its best-selling product this year.
- Hikma, which is partnered with Vectura in development of the generic, said the FDA had flagged "major" issues with the application, although no concerns regarding the substitutability of Hikma's device with GSK's inhaler were raised in the complete response letter.
- In March, the FDA had turned down an application from Mylan for approval of its generic Advair copy, giving GSK some breathing room. The pharma had forecast U.S. Advair sales to decline by as much as 45% if a substitutable generic launched by mid-year.
With the threats from both Mylan and Hikma pushed off for now, GSK's newly minted CEO Emma Walmsley has more time to manage the expected hit to the company's bottom line.
GSK has said it expects core earnings per share for 2017 to grow between 5% and 7% if no generic is launched this year. Approval of either copycat drug would likely have meant flat or declining earnings.
Hikma said it currently believes "there is a low likelihood of approval this year" for its generic, but plans to work with the FDA to address the complete response letter (CRL).
CRLs classified as major typically require 10 months to resolve, according to FDA guidelines. On Wednesday, Mylan disclosed in an earnings call with analysts that its CRL had been designated as major, although Mylan President Rajiv Malik said the company hopes to change that classification.
Advair, which is also approved for COPD, has been GlaxoSmithKline's top-selling drug for years, historically accounting for nearly 20% of overall product sales.
Sales have begun to erode, though, as branded competition eats away at GSK's market share. Entry of a substitutable generic — a copy which can be swapped for the brand by a pharmacist — would precipitate a rapid collapse of U.S. sales.
Teva actually won approval in January for its AirDuo Respiclick, an inhaler-drug combo which uses the same active pharmaceutical ingredients as Advair. But the product is only approved for treatment of asthma in patients older than 12, and is not directly substitutable with GSK's drug.
GSK hopes its successor respiratory drugs, along with a growing HIV business, can help offset the damage an Advair generic would do to its cash flow. While it's not yet clear if that strategy will be enough, GSK now has more time to ease the likely painful transition.