Generic name: bevacizumab
2015 sales: $6.95 billion
2022 sales: $4.68 billion
Current indications: colorectal cancer; non-small cell lung cancer; ovarian cancer; cervical cancer; renal cell carcinoma; glioblastoma
Avastin has been the gift that just keeps on giving for Roche. The VEGF-targeting antibody claimed its first approval in colorectal cancer in 2004 and has steadily added new indications since then, most recently picking up a European approval for use alongside Tarceva for patients with EGFR-positive non-small cell lung cancer.
Despite its age, Avastin is currently Roche's second biggest-selling drug (routinely swapping places with breast cancer stalwart Herceptin), and the company is still not done trying to add to its label. A filing in mesothelioma is expected to take place in 2017, and if studies of Avastin plus Tecentriq in renal cell carcinoma and non-small cell lung cancer go according to plan, the combination could be submitted to regulators the following year.
Avastin sales rose 9% in 2015 due to rising demand in ovarian, colorectal, lung and cervical cancer, particularly in Europe and emerging markets. The franchise has had a few drawbacks—notably a failure to win approval for breast cancer in the U.S. in 2010 followed by restrictions on its use in breast cancer in Europe, where it was also rejected for brain cancer in 2014.
But Avastin's upward trajectory is likely to falter now that biosimilar versions of the drug are hitting the market. These are already on the market in emerging markets, notably India and Russia; Amgen and Allergan have announced plans for "global regulatory submissions" for their version in 2016; and Biocon and partner Mylan have a version under review in the EU. They will have a fight on their hands, with Roche reckoning it has patent protection for Avastin in the U.S. until 2019 and in Europe until 2022.
Several other manufacturers—including Samsung Bioepis, Boehringer Ingelheim, Pfizer, AryoGen Biopharma, Reliance Life Sciences and Fujifilm Kyowa Kirin Biologics—have Avastin biosims in phase 3. EvaluatePharma is only expecting the brand to lose a couple of billion dollars by 2022, though, keeping it among the top 10 cancer drugs.