Oncology

The Center for Biosimilars® recaps the top stories for the week of January 6.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

The findings indicate that interventions that leverage physician relationships may assist with increasing uptake of new, high-value cancer treatments in place of low-value therapies.

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses what she will be watching closely in the biosimilars space in early 2020.

Lee Schwartzberg, MD, FACP, executive director, West Cancer Center, discusses how patients are responding to using biosimilars.

Tesh Khullar, senior vice president and advisor, Flatiron Health, discusses biosimilar education for patients and providers.

Given that anti–tumor necrosis factor (anti-TNF) agents are able to suppress mucosal inflammation, some have posited that these drugs could play a role in mitigating immune-related enterocolitis.

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses how anticancer biosimilars have played a role in oncology in 2019.

During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar filgrastim could result in substantial savings.

While biosimilars approved by regulators have been shown to have no clinically meaningful differences from their reference products, this week, during the San Antonio Breast Cancer Symposium, held in San Antonio, Texas, researchers will report reassuring data for biosimilar trastuzumab, Ogivri, showing that the combination of the biosimilar with pertuzumab is highly similar to the combination of the reference drug with pertuzumab.

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Celltrion and Teva’s biosimilar rituximab, CT-P10, Truxima, recently launched in the United States. The product is the first rituximab biosimilar to become available to US patients, and during this week’s 61st meeting of the American Society of Hematology (ASH), 2 research teams presented data that highlight the biosimilar’s safety and efficacy in patients with lymphoma.