Oncology

The FDA has approved a multidose vial of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which was first approved as a 150-mg single-dose vial in January 2019 and has yet to reach the US market in either form.

As coronavirus disease 2019 (COVID-19) causes medical systems to bog down from a host of related issues, a UT Health expert said clinical trials likely will be powered down and hospitals will put consideration of newly available agents on hold.

By 2023, patents on nearly 20 oncology biologics will expire, which could lead to more biosimilars in cancer care and therefore reduced costs, according to a review article.

Biosimilars are starting to gain some traction in the marketplace, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

In case you missed it: Jeffery Scott, MD, chief medical officer of Integra Connect, discussed what role biosimilars will play in a value-based system on a recent podcast episode of Not So Different.

Panelists at the 2020 Specialty Therapies and Biosimilars Congress discussed the strategies needed to get biosimilars to market and overcome obstacles by originator product manufacturers.

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.

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.