4. Avastin

Avastin is Roche's third cancer blockbuster facing potential biosim competition this year. (Roche)

Company: Roche
2018 U.S. sales: $2.90 billion
Disease: Metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma and certain other cancers
Competition expected: Second half of 2019

Avastin is Roche’s third cancer blockbuster expected to come up against 2019 biosimilar competition in the U.S. Again, executives declined to quantify the amount of lost sales due to biosims this year, but Roche has billions at stake as biosims creep to the critical market.

Approved in 2004, Avastin treats several types of cancers, including metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma and metastatic renal cell carcinoma. The drug generated a little over $2.9 billion in the U.S. last year, falling just behind Roche’s Herceptin. Since it made its market debut, Avastin has pulled in more than $48 billion in the U.S. alone.

Amgen has already scored approval for its Avastin biosimilar, called Mvasi, while Pfizer, Samsung and Celltrion are among biosim makers working on copycats. In Europe, Pfizer in December won a positive opinion from a European Medicines Agency committee, setting its biosimilar up for a likely approval. 

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Roche also expects Avastin’s fellow cancer drugs Rituxan and Herceptin to face U.S. biosim competition this year. Together, those three drugs delivered U.S. sales of $10 billion in 2018.

As its trio of top-sellers comes under new pressure, Roche is hoping newer meds can take off. One already has in a big way—multiple sclerosis med Ocrevus reached sales of $2.35 billion in 2018 after its launch the prior year. Roche’s new hemophilia med Hemlibra carries blockbuster expectations, and the company recently won approval for  Xofluza, which the FDA called the first antiviral flu treatment with a novel mechanism of action in two decades.

And then there’s Roche’s new generation of cancer drugs, including Perjeta and Kadcyla, which are looking to hold their own in HER2-positive breast cancer even as new biosims take a bite out of the stalwart Herceptin. The newer PD-L1 immunotherapy, Tecentriq, is also looking for traction as Roche continues to build out its cancer pipeline.

4. Avastin