Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer and has significantly improved the survival of these patients and become the standard of care, according to Arlene Chan, MB BS, FRACP, MMed, writing in Chinese Clinical Oncology.
Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer with encouraging results. It has significantly improved the survival of these patients and become the standard of care, according to an editorial by Arlene Chan, MBBS, FRACP, MMed, writing in Chinese Clinical Oncology. However, the cost of 12 months of adjuvant trastuzumab therapy, the standard duration of treatment, as well as the cost associated with indefinite use in a metastatic setting, limits patient access to this life-saving drug.
According to Chan, a study published in the Lancet Oncology that evaluated trastuzumab’s limited availability in China, India, and Russia (which make up 40% of the world’s population) showed that only one-third of HER2-positive breast cancer patients in China had access to trastuzumab. The study also demonstrated equivalence of the biosimilar, CT-P6, with reference trastuzumab in the primary outcome measure of pathological complete response (pCR). In line with the FDA’s guidance on using pCR as an endpoint in high-risk early-stage breast cancer following neoadjuvant therapy to support accelerated drug approval, the use of pCR is an appropriate clinical endpoint to demonstrate equivalence of the 2 molecules, said Chan.
With respect to safety, incidence of treatment emergent adverse events appeared to be balanced between the 2 agents. The administration of concurrent anti-HER2 agent with the anthracycline component of neoadjuvant treatment did not show differences in rates of symptomatic cardiac dysfunction, though cardiac function follow-up was only reported until the end of the neoadjuvant phase of treatment. Investigators will also perform a follow-up for disease events for a minimum of 3 years from the enrollment of the last patient to ensure that the equivalent efficacy is maintained.
According to Chan, the real benefit of the study will be determining whether the presumed lower drug costs of the biosimilar translate into greater utilization of this targeted therapy, especially for those who do not currently receive this treatment. The healthcare community is waiting to see whether increasing availability of trastuzumab biosimilar agents will change clinical practice as the financial barriers are lowered.
It will also be important, says Chan, to measure certain outcomes as more biosimilars enter the clinical setting for breast cancer and HER2-positive solid tumors. These outcomes will include institutional and national data collection to show that more patients are receiving this therapy, as well as cost savings that are presumed for health care providers.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.