Biosimilar Oncology Roundup: March

March 2018 saw a variety of developments for biosimilars in cancer care, both in the United States and abroad.

Biosimilar trastuzumab has arrived in Europe.

Merck, operating under the trade name MSD in Europe, announced this month that it has launched Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, in the United Kingdom. The biosimilar, also known as SB3, references Roche’s Herceptin, and is approved to treat early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The biosimilar also launched in the Republic of Korea this month under the brand name Samfenet.

Other biosimilars are close on Ontruzant’s heels in the European Union: Amgen and Allergan have gained a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for ABP 980, and Korean drug maker Celltrion has announced that its biosimilar, Herzuma, will be distributed in 7 EU nations by Mundipharma.

Real-world experience supports using rituximab—and its biosimilars—in oncology.

European data show that using rituximab plus a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for patients with diffuse large B-cell lymphoma (DLBCL) can produce “excellent outcomes,” and UK data demonstrate that rituximab is more cost effective than a watch-and-wait approach to treating patients newly diagnosed with asymptomatic advanced follicular lymphoma.

Additionally, a recent study found that more than 90% of patients in India who had DLBCL from 2014 to 2015 had access to rituximab because a biosimilar had become available in the national marketplace. The complete response rate improved for these patients versus those who received CHOP alone, as did 5-year overall survival.

The supportive care landscape is changing.

As regulators in the European Union and the United States consider pegfilgrastim biosimilars, Amgen is changing its approach to selling reference pegfilgrastim (Neulasta); the EMA’s CHMP has issued a positive opinion for Neulasta Onpro, an on-body delivery device that allows a patient to forego a visit to the physician’s office to receive an injection of the drug. The Onpro kit is already approved in the United States.

Meanwhile, drug maker Spectrum Pharmaceuticals is developing eflapegrastim, a novel long-acting granulocyte-colony stimulating factor therapy that has demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when the products are administered at similar doses.

A literature review of switching studies may help to allay providers’ concerns.

Despite the fact that no new safety or efficacy concerns have been detected in more than 10 years and 700 million patient-days of experience with biosimilar medicines, some stakeholders remain cautious about switching patients from reference products to biosimilars. A systematic literature review published this month may help to allay those concerns; in 90 switching studies that enrolled over 14,000 unique individuals, switching from a reference biologic to a biosimilar did not result in a significant difference in anti-drug antibodies or neutralizing antibodies in patients who switched versus patients who did not, and there were no reported increases in treatment-related safety events—including loss of efficacy—in patients who switched.

US oncologists are eager for biosimilars and their cost-saving potential.

Global experience with anticancer biosimilars like rituximab and trastuzumab notwithstanding, no such drugs have become available in the US market to date, and providers are increasingly eager to have the option to use biosimilars. During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network, held in March in Orlando, Florida, Lee Schwartzberg, MD, FACP, of the University of Tennessee Health Science Center, said that nearly half of US spending on oncology comprises the cost of drug therapies, and that the cost of the reference trastuzumab has continually risen over the past decade. Today, a single year of trastuzumab for an individual patient costs approximately $70,000 to $80,000, and the market entry of a biosimilar could play a critical role in reducing the cost of care.

The FDA is planning new policies to encourage biosimilars.

In a speech delivered at America’s Health Insurance Plans’ National Health Policy Conference, Scott Gottlieb, MD, Commissioner of the FDA, spoke candidly about the state of the biosimilars market in the United States. According to Gottlieb, “the economics of development are currently unstable, and the pipeline of biosimilar products that we hope for could be dramatically affected by the weakening of market incentives to bring these products to patients.” He added that “the rigged payment scheme might quite literally scare competition out of the market altogether. I fear that’s already happening.”

To encourage the market entry of biosimilars, Gottlieb said in an interview with CNBC’s Meg Tirrell at the Healthy Returns conference, the FDA is “advancing new policies to try to stimulate more biosimilar development. We're taking a hard look at how we determine interchangeability so that we can make determinations that biosimilars can be used interchangeably with the brand of drugs.” Additionally, the agency is considering forcing brand-name biologics makers to “tighten up” manufacturing processes to minimize product drift—a step that could make biosimilar development easier.