Bye-bye, blockbuster? AstraZeneca's Faslodex gets U.S. generic on heels of record sales year

AstraZeneca rightly celebrated its longtime breast cancer therapy Faslodex reaching blockbuster status in 2018 for the first time. But one year later, with a first-ever Faslodex generic hitting the market stateside, what can AstraZeneca expect from the drug’s future?

On Thursday, Novartis’ Sandoz unit launched its generic version of Faslodex (fulvestrant) as a solo or combination therapy for HR-positive metastatic breast cancer, threatening AstraZeneca’s $541 million in annual U.S. sales as of March 2019. The fulvestrant generic is part of Sandoz’s renewed push into the oncology generic market, Novartis said in a release.

“Fulvestrant is an important treatment option for women with advanced breast cancer and we will work to help those in the U.S. who need this critical therapy have access to it at an affordable price,” Sandoz President Carol Lynch said.

The bad news for AstraZeneca followed a series of wins for the nearly 20-year-old Faslodex after positive phase 3 trial data in late 2017 showed the drug’s promise as a solo treatment for breast cancer in post-menopausal women who haven’t undergone endocrine therapy and as a combo therapy with CDK 4/6  inhibitors. In fact, by the end of 2018, Faslodex had been approved as a backbone treatment for most of the CDK 4/6 inhibitor class treating HR-positive, HER2-negative breast cancer, the company said.  

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Those wins translated into all-time-high sales for Faslodex, with more than $1 billion in global revenue in 2018 and $537 million in U.S. sales. Those global figures were an impressive leap from $941 million in 2017 and an even more impressive leap from $830 million in 2016.

The launch of Novartis’ generic followed a court settlement in July 2016 putting off U.S. generic competition until March 2019, according to company filings. AstraZeneca filed a separate injunction in June 2018 to stop the generic’s launch in France, which was rejected by a French court.

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Despite Faslodex’s setback, AstraZeneca has seen remarkable gains in the past year from its oncology portfolio with EGFR inhibitor Tagrisso snagging the company’s top-performer spot in the first quarter of 2019 with $630 million in sales. In total, AstraZeneca posted $1.89 billion in sales from its oncology portfolio in the first quarter of the year, a 59% increase on the year.

AstraZeneca has also benefitted from its push into emerging markets, beating out longtime leader Pfizer in terms of pharma sales in China in the year’s first quarter. Iressa, a predecessor to Tagrisso that has been nearly squeezed out of the global market by its follow-up, saw a 13% increase in sales in the first quarter. Those gains were largely due to a strong performance in China, where the drug cleared $134 million on the quarter.