Roche doomsday is here: Long-feared Herceptin, Avastin biosims bust into U.S. market

Roche
Roche's legacy oncology blockbusters Herceptin and Avastin could be in danger after Amgen and Allergan launched their biosimilar copies at a 15% premium. (Roche)

For years, Roche’s blockbuster oncology troika—Rituxan, Herceptin and Avastin—dominated sales stateside and abroad. For two drugs in that superstar trio, though, those landmark years could be approaching an end.

Amgen and Allergan Thursday launched U.S. biosimilars of both HER2-positive breast cancer med Herceptin and colorectal cancer treatment Avastin, threatening a combined $5.9 billion in U.S. sales in 2018. Amgen’s Avastin biosim, Mvasi, was the first oncology biosim approved by the FDA in late 2017, and the agency approved Herceptin biosim Kanjinti in June.

Both drugs will launch at a wholesale list price 15% cheaper than their reference biologics, the companies said. For Mvasi, that means a price of $677.40 per 100 milligrams and $2,709.60 per 400 mg single-dose vial. Kanjinti will hit the market at $3,697.26 per 420 mg multidose vial.

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"Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the U.S., which will provide for immediate savings for Medicare patients and commercial payers,” Murdo Gordon, Amgen’s commercial chief, said in a statement. “We have several more biosimilars advancing through our pipeline, even as we continue to drive innovation through novel therapies for cancer and other serious diseases."

RELATED: The top 20 drugs by 2018 U.S. sales | Herceptin, Avastin

For Amgen and Allergan, the only drugmakers that chose not to cut a delayed launch date deal with Roche for their biologics, holding out on a settlement could provide major dividends in sales—and provide a gloomy forecast for other competitors.

Bengalaru, India-based Biocon, a partner of Mylan's on a Herceptin biosim approved back in late 2017, was trading down 8.17% Thursday on the Bombay Stock Exchange after the news broke. Mylan was one of a group of drugmakers that reached an agreement with Roche not to launch Herceptin biosims until mid- to late 2019, including Pfizer, Samsung Bioepis and the Teva Pharmaceutical-Celltrion team.

RELATED: Roche’s patent cliff just got steeper as FDA approves Celltrion’s Rituxan biosimilar Truxima

With Herceptin and Avastin expected to take major sales hits with the wave of biosims approaching, Roche’s top-performing Rituxan—with $4.24 billion in U.S. sales in 2018—could be next.

Teva and Celltrion are expected to launch Truxima, their Rituxan biosim, at some point this year. A Rituxan copy from Fosun Pharma’s Shanghai Henlius Biotech was the first-ever biosim approved in China, foreshadowing the legacy megablockbuster’s continued decline overseas. In Europe, where Rituxan biosims have already dropped, sales of the drug plummeted 46% in the fourth quarter of 2018.

RELATED: Roche's drugs, new and old, team up for major sales—sans price hikes

With Herceptin’s sales chances expect to slip, Roche is leaning into its stable of newer drugs including HER2-positive breast cancer med Kadcyla, PD-L1 inhibitor Tecentriq, hemophilia med Hemlibra and multiple sclerosis therapy Ocrevus, which Roche has touted as its best launch ever. 

In the first quarter, the trio of Rituxan, Avastin and Herceptin actually outperformed analyst consensus, but the drugmaker's newer offerings significantly outshot analysts' forecasts, with Ocrevus leading the way. The drug registered first-quarter sales of CHF 836 million ($829 million), beating consensus by CHF 111 million, or 15%. Meanwhile, Hemlibra doubled its first-quarter sales from the previous year to CHF 219 million ($217 million), beating analyst expectations by 62%.

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