Roche Sues Pfizer to Block Its Biosimilar Referencing Herceptin

Roche is suing Pfizer Inc. to block the company from selling a biosimilar of its breast-cancer drug Herceptin in the United States, according to an article in Bloomberg Technology.

According to a complaint filed in a Delaware federal court by Roche’s Genentech unit, Pfizer’s proposed biosimilar would infringe on 40 of its patents. Roche also wants compensation for lost sales if Pfizer continues with the launch of its product before patents related to Herceptin expire, which some will begin to do in 2019.

The drug brought in $2.5 billion of revenue in the United States in 2016, which was 5% of Roche’s annual revenue, according to Bloomberg Data.

“We will respond in court at the appropriate time,” said Pfizer spokesman Thomas Biegi in a statement. “We’re committed to making this important treatment option available to physicians and patients.”

Pfizer is seeking FDA approval of its version of Herceptin biosimilar, PF-05280014. Pfizer's Hospira unit is targeting the patents Roche’s Genentech has on Herceptin; in July, the Patent Trial and Appeal Board agreed to review the validity of 3 Genentech patents, and decisions are expected next year.

Herceptin, which was approved by the FDA in 1998, uses trastuzumab to target the mechanism that makes certain types of breast cancer especially aggressive. About 1 in 4 US women with breast cancer have this aggressive form of the disease, a diagnosis that Roche said was once considered, “effectively a death sentence.”

As biosimilars prepare to enter the market, 3 of Roche’s biggest cancer medicines have seen cheaper versions of the complex biologic drugs come into play, thus affecting revenue.

Roche is depending on new drugs such as Ocrevus, a multiple sclerosis therapy, to drive revenue as Herceptin, Rituxan, and Avastin face oncoming competition from cheaper biosimilars and other newer treatments. In April, Sanford C. Bernstein & Co. said the company would lose close to $4 billion in sales from the cheaper treatments in 2020. Roche has previously said that competitors of Rituxan and Herceptin will most likely have an effect on revenue in 2018.