Herceptin and Avastin Biosimilars Enter U.S. Market, Marking a Turning Point for Roche

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For years, Roche’s blockbuster oncology “troika”—Rituxan, Herceptin, and Avastin—has dominated the sales charts for oncology drugs both domestically and internationally. However, for two of these agents, those milestone years may be coming to an end.

Recently, Amgen and Allergan announced the launch of Mvasi and Kanjinti in the US market. These two drugs are biosimilars of Avastin and Herceptin, respectively. Mvasi was approved by the US FDA in September 2017 for the treatment of five types of cancer: metastatic colorectal cancer in combination with chemotherapy; non-squamous non-small cell lung cancer in combination with chemotherapy; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent, or metastatic cervical cancer in combination with chemotherapy. Kanjinti was approved in June 2019 for all indications approved for Herceptin, including: adjuvant treatment of HER2-overexpressing breast cancer; HER2-overexpressing metastatic breast cancer; and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Avastin and Herceptin are the two best-selling oncology drugs globally, with 2018 worldwide sales of CHF 6.849 billion and CHF 6.982 billion, respectively. In the United States, their combined sales in 2018 totaled $5.9 billion.

Regarding pricing, Amgen and Allergan stated that the wholesale acquisition costs of Mvasi and Kanjinti would be 15% lower than those of the reference products. Specifically, Mvasi is priced at $677.40 for a 100 mg single-dose vial and $2,709.60 for a 400 mg single-dose vial, while Kanjinti is priced at $3,697.26 for a 420 mg multi-dose vial.

Murdo Gordon, Commercial Lead at Amgen, stated in a press release: “Following the launch of several biosimilars in Europe, we are pleased to introduce the first two biosimilars in the U.S. market, which will help reduce costs for Medicare beneficiaries and commercial payers.”

It is worth noting that Amgen and Allergan were the only pharmaceutical companies that chose not to sign agreements with Roche to delay the market launch of biosimilars. Ogivri, developed by Indian pharmaceutical company Biocon in collaboration with Mylan, received FDA approval in December 2017, becoming the first trastuzumab biosimilar approved by the agency. Following the announcement of Kanjinti’s market launch, Biocon’s stock price fell by 8.17%. Mylan was among the pharmaceutical companies that signed delay agreements with Roche; other signatories included Pfizer, Samsung Bioepis, and the Teva-Celltrion consortium. These companies committed to not launching trastuzumab biosimilars in the U.S. market before mid-to-late 2019.

As the wave of biosimilars approaches, the sales performance of Herceptin and Avastin is expected to take a significant hit, while Roche’s other blockbuster drug, Rituxan, may become the next target. The drug achieved global sales of CHF 6.752 billion in 2018, with $4.24 billion generated in the U.S. market, making it Roche’s best-performing product in the United States.

Teva and Celltrion are expected to launch Truxima, a biosimilar of Rituxan, later this year. In addition, Henlixin, the Rituxan biosimilar developed by Henlius Biopharma, received approval from the National Medical Products Administration in February this year, becoming the first approved biosimilar drug in China. In the European market, sales of Rituxan plummeted by 47% in 2018 due to the impact of biosimilars.

Although sales forecasts for Avastin and Herceptin are expected to face headwinds, Roche’s portfolio of newly launched drugs is anticipated to offset these losses. These include Ocrevus for multiple sclerosis, Perjeta for breast cancer, the PD-1 cancer immunotherapy Tecentriq, and Hemlibra for hemophilia. In particular, Roche has hailed Ocrevus as the best product it has ever launched. Approved in the United States in March 2017 and in the European Union in January 2018, Ocrevus is indicated for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Administered via intravenous infusion every six months, with only two infusions required per year, the drug significantly improves patient adherence to treatment.

Ocrevus is the first and only disease-modifying therapy approved for the treatment of both types of multiple sclerosis, as well as the first and only disease-modifying therapy for primary progressive multiple sclerosis (PPMS). In 2018, global sales of Ocrevus reached CHF 2.358 billion, with the U.S. market contributing CHF 2.080 billion.

In the first quarter of this year, the performance of Rituxan, Avastin, and Herceptin exceeded industry expectations, while sales of new products significantly surpassed those expectations. Among them, Ocrevus took the lead, with first-quarter sales reaching CHF 836 million, 15% higher than the consensus estimate of industry analysts. Meanwhile, Hemlibra’s first-quarter sales doubled compared to the same period last year, reaching CHF 219 million, which was 62% above the consensus estimate of industry analysts.

On the other hand, supported by new indications, Tecentriq’s sales grew rapidly, doubling in the first quarter to reach CHF 336 million, and it is expected to join the ranks of blockbuster products in 2019. In 2019, Roche will also launch several products with greater blockbuster potential, including the “tumor-agnostic” broad-spectrum anticancer drug entrectinib and the novel CD79b-targeted antibody-drug conjugate polatuzumab vedotin. Meanwhile, the company will submit regulatory applications for several new drugs, including risdiplam, which has the potential to become the world’s first oral treatment for spinal muscular atrophy (SMA).

Analysts predict that despite the impact of biosimilars on Roche’s three major cash-cow brands, the company remains capable of sustaining growth.

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