Hikma is offering everolimus tablets in dosage strengths of 2.5 mg, 5 mg, and 7.5 mg.
The product is the generic of Novartis’ Afinitor.
Everolimus is indicated for the treatment of adult patients with advanced renal cell carcinoma after failure of treatment with Sunitinib or Sorafenib. It also is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery.
“We are very pleased to add a generic version of Afinitor to our portfolio and improve patient access to this important medicine,” said Brian Hoffmann, Hikma president of generics. “Building a portfolio of more complex, differentiated products is a key element of our strategy and this launch demonstrates our ability to successfully litigate and provide patients with high-quality, affordable medicines.”
Everolimus tablets had a market value of roughly $435 million in the 12 months ended April 2020, according to IQVIA.