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Biosimilar Oncology Roundup: April 2022


New information on oncology biosimilars have sprouted during the month of April, including an FDA approval, study results from conferences, and data on pegfilgrastim biosimilar utilization and spending.

New information on oncology biosimilars have sprouted during the month of April, including an FDA approval, study results from conferences, and data on pegfilgrastim biosimilar utilization and spending.

Bevacizumab Advances

The biggest news to come out of April was the FDA approval of bevacizumab-maly (Alymsys), a biosimilar to Avastin (reference bevacizumab). The approval marked the third bevacizumab biosimilar approval in the United States and the second product approval for Amneal Pharmaceuticals.

Additionally, Roche’s earning for the first quarter of 2022 revealed that the company’s revenue for Avastin were down 32% compared to the first quarter of 2021. Roche cited growing biosimilar competition as the main reason for the decline. The company also saw declines in sales for Herceptin (reference trastuzumab) and Rituxan (reference rituximab) due to biosimilar competition.

Conference Updates

New phase 3 study results showing that Celltrion Healthcare’s bevacizumab biosimilar (CT-P16) was effective in treating patients with non-small cell lung cancer. Bevacizumab products are indicated for the treatment of colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancers and is sometimes used off-label for the treatment of neovascular age-related macular degeneration (wet AMD).

The study showed that the biosimilar was equivalent to the reference product in terms of safety and efficacy and achieved positive overall response rates in patients with metastatic or recurrent adenocarcinoma of the lung. The results were presented at the American Association of Cancer Research annual meeting.

During a session at the Academy of Managed Care Pharmacy meeting, strategies used to encourage biosimilar utilization in the oncology space led to cost savings. Presenter Yuqian Liu, PharmD, director of specialty clinical solutions at Magellan Rx Management, highlighted a survey conducted by her organization that found that utilization of bevacizumab, trastuzumab, rituximab, filgrastim, and epoetin alfa biosimilars across the 41 surveyed payers increased dramatically from the fourth quarter of 2020 to the third quarter of 2021.

Additionally, a poster from the same meeting demonstrated real-world evidence finding that trastuzumab-anns (Kanjinti) was comparable to the reference product in safety and efficacy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Although the noninferiority in early HER2-positive had been established in older studies, the evolution of real-world outcomes can help contribute information on the utilization of the biosimilar and support providers in treatment decision-making.

Pegfilgrastim Biosimilar News

Early in April, the European Commission authorized Fresenius Kabi’s pegfilgrastim biosimilar (Stimufend), which references Neulasta (reference pegfilgrastim), for marketing across the European Union. Stimufend represented Fresenius Kabi’s first European approval for an oncology biosimilar and second one overall.

Pegfilgrastim products are used in patients with nonmyeloid cancer who are undergoing myelosuppressive chemotherapy and are at risk of febrile neutropenia.

Additionally, a study assessing real-world dosing and effectiveness of pegfilgrastim biosimilars demonstrated that the clinical benefits of preventing febrile neutropenia in patients who are at an intermediate to high risk come at a financial cost similar to those associated with filgrastim biosimilars, which reference Neupogen.

The total costs estimated for the pegfilgrastim biosimilars were around $120,000 compared with the costs for filgrastim biosimilars (around $108,000) for the high risk group. The intermediate risk group had slightly higher costs for the pegfilgrastim biosimilars compared with the filgrastim biosimilars (about $107,000 vs $105,000, respectively).

Lastly, a report from the HHS Office of Inspector General found that Medicare Part D plans missed out on between $85 million and $143 million in savings by not prioritizing biosimilars over reference products. Of the 8 biosimilars that were covered under Medicare Part D in 2019, 3 were filgrastim products, 2 were infliximab biosimilars, 2 were pegfilgrastim products, and 1 was an epoetin alfa biosimilar.

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