Afinitor (everolimus) has been marketed in the US by Novartis. A derivative of rapamycin (also known as sirolimus), it inhibits the mTOR protein to limit cancer growth. The small molecule drug can be used to treat various cancer types including advanced kidney cancer, pancreatic neuroendocrine tumours and some forms of breast cancer.

In December 2019, FDA approved two generic versions of the drug, manufactured by Israeli generics giant Teva and US firm Par Pharmaceutical. Both firms gained approval for everolimus tablets in 2.5 mg, 5 mg, and 7 mg doses, while Teva also gained approval for the drug in a higher 10 mg dose, which may give them a competitive advantage.

Domenic Ciarico, a representative of Endo International (which operates Par Pharmaceutical), said: ‘We are pleased to bring the first generic Afinitor to market and provide patients with a lower-cost option’.

FDA followed this with the approval of a generic version of Uloric (febuxostat) in January 2020. Febuxostat is a small molecule treatment for long-term gout caused by high uric acid levels, marketed by Takeda in the US. It has been approved in the US since 2009 where the wholesale cost for a month is approximately US$320.

The Administration approved a generic version from Indian drug manufacturer MSN Laboratories, through their US-based sales and marketing affiliate Novadoz Pharmaceuticals (Novadoz).

Novadoz say they have already started shipping 40 mg and 80 mg doses of the drug, available in bottles of 30 tablets. The treatment will be available to patients with gout who have a poor response to a maximally titrated dose of rival drug allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

President of North America Generics for Novadoz Seshu Akula commented on the news, which is the 12th product introduction for Novadoz. ‘Our vertical integration through MSN, the #1 API supplier in the world, continues to define our success now and in the future. We expect continued success in 2020 with multiple product approvals, including several in the specialty oncology space’.

Tom DeStefano, VP for Sales and Marketing at Novadoz added: ‘2019 had many successes in our first full year of operation. We have gratitude for the customers that placed confidence in our ability to supply high volume, and specialty products. Our successful supply chain management ensures customers on-time order fulfilment. The FDA approval of Febuxostat furthers our emergence as a future leader in the generic pharma industry’.

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