Roche Holding AG, facing pressure in Europe as cheaper biosimilars of its three biggest cancer medicines chew away at its revenue, sued to block Pfizer Inc. from selling a copy of its breast-cancer drug Herceptin in the U.S.
Pfizer’s proposed biosimilar, as copycat versions of complex biologic drugs are known, would infringe 40 patents, Roche’s Genentech unit said in a complaint filed Friday in federal court in Wilmington, Delaware. Roche also wants compensation for lost sales if Pfizer launches its product before patents related to Herceptin expire, as some will begin to do in 2019.
The suit is Roche’s first in the U.S. involving a biosimilar version of Herceptin. Genentech’s parent, which is based in Basel, Switzerland, is trying to protect a drug that earned 2.5 billion Swiss francs ($2.5 billion) in U.S. sales in 2016. That was 5 percent of Roche’s annual revenue, according to Bloomberg data.
Herceptin, which the U.S. Food and Drug Administration approved in 1998, uses an antibody called trastuzumab to target the mechanism that makes certain types of breast cancer especially aggressive. About a quarter of the 2.8 million U.S. women with breast cancer have the aggressive form of the disease, a diagnosis that Roche said was once considered “effectively a death sentence.”
Pfizer is seeking FDA approval of its version of Herceptin, called PF-05280014.
“We will respond in court at the appropriate time,” Pfizer spokesman Thomas Biegi said. “We’re committed to making this important treatment option available to physicians and patients.”
Roche is leaning on new drugs such as the multiple sclerosis therapy Ocrevus to drive growth as its three most lucrative drugs — the cancer-fighting trio of Herceptin, Rituxan, and Avastin — face competition from biosimilars or newer treatments. The company could lose almost $4 billion in sales to the cheaper versions of the three drugs in 2020, Sanford C. Bernstein & Co. said in April. Roche has said that competition for its two best-selling medicines, Rituxan and Herceptin, will probably start to have an impact on revenue in 2018.
Pfizer’s Hospira unit is trying to chip away at the trove of patents Roche’s Genentech has on Herceptin. In July, the Patent Trial and Appeal Board agreed to review the validity of three Genentech patents, with decisions expected next year.
The head of a breast cancer center who helped test the original Herceptin said in September that Pfizer’s would-be competitor works just as well for patients whose tumors have spread.
The European Commission on Sunday approved Samsung Bioepis Co. Ltd.’s Ontruzant, a biosimilar of Herceptin. Biosimilars of Herceptin also will start to have an impact in Europe this quarter and into the coming year, Daniel O’Day, Roche’s pharma chief, said in an October conference call.
Europe is far ahead of the U.S. in the use of biosimilars. In the seven years since Congress passed legislation for such copycats, regulators in the U.S. have approved five biosimilars, compared to 25 such drugs now available in Europe. The slow path to market in the U.S. has frustrated makers of biosimilars and patients who hope the presence of more competitors will cause drug prices to decline.
Regulatory approval isn’t the only hurdle for copies of biotechnology drugs like Herceptin. The drugs are complex, and it’s not unheard of for one to be tied to more than 100 patents, which can generate extensive litigation. And drugmakers may use contracts with drug plans and insurers to thwart competitors.
Genentech, with headquarters in South San Francisco, was bought by Roche in 2009 for $46.8 billion.
The case is Genentech v. Pfizer, 17-cv-1672, U.S. District Court, District of Delaware (Wilmington).
Article Source: Bloomberg