Susan G. Komen Releases Biosimilar Points to Consider for Patients With Breast Cancer

With trastuzumab biosimilars expected on the US market soon for HER2-positive breast cancer, an advocacy organization for patients with breast cancer said recently that it wants to provide education about the potential of the medicines to lower costs and provide more treatment options.

Trastuzumab attaches to the HER2 protein on the surface of the cancer cell, slowing or stopping the cancer cell from growing. In the US market, patents on Roche’s Herceptin, the originator trastuzumab, are expiring this year, clearing the way for competitors.

Biosimilars of trastuzumab have already entered the European market, and in the United States, 5 biosimilars (Ogivri, Kanjinti, Herzuma, Ontruzant, and Trazimera) have been FDA approved, though none are yet available to patients.

“The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers. As patient advocates, we are working to ensure that patients are educated about biosimilars and can feel comforted that they are FDA approved and just as safe and effective as the original biologic drug,” said Paula Schneider, chief executive officer of Susan G. Komen, in a statement.

Susan G. Komen said there are 4 things it wants patients to know about biosimilars:

• Biosimilars are not exactly like generic drugs, which are identical copies of chemicals used to create a small-molecule drug, but they are “highly similar.” The small differences that exist don’t affect how biosimilars work, the statement noted.
• Biosimilars are just as safe and effective as the original biologic drug, and do not have any “clinically meaningful” differences in safety, purity, strength, or potency.
• Biosimilars will provide more treatment options.
• As with other patient advocacy organizations, Susan G. Komen is stressing that biosimilars should help reduce overall healthcare costs and that as more biosimilars enter the market, competition may reduce future costs. For now, though, the direct financial impact on patients is unclear.

Breast cancer groups are also preparing for the introduction of trastuzumab biosimilars in Canada, where biosimilars have been available since 2009. Health Canada approved its first trastuzumab biosimilar, Mylan and Biocon’s Ogivri, in May.