pCR rates were similar for patients treated with [Ogivri] compared with [Herceptin] in our real-world study of HER2+ neoadjuvant [early breast cancer] and comparable to pivotal phase 3 trials.
Investigators further elucidate the equivalence of a trastuzumab biosimilar vs Herceptin in human epidermal growth factor receptor 2–positive (HER2+) breast cancer.
Investigators in Alberta, Canada, said no significant differences in pathologic complete response rates (pCRs) were observed in a study of patients with human epidermal growth factor receptor 2–positive (HER2+) treated with the biosimilar trastuzumab Ogivri vs the originator product, Herceptin.
pCR rates were similar for patients treated with [Ogivri] compared with [Herceptin] in our real-world study of HER2+ neoadjuvant [early breast cancer] and comparable to pivotal phase 3 trials.
The study authors postulated that although biosimilars are certified as having no clinically meaningful differences from originator products, there is potential for clinically meaningful differences in outcomes because biosimilar manufacturers must produce new cell lines to replicate originator biologics and are not given access to the originator cell lines.
Concerns about “this inherent alteration in production” are settled through phase 1 pharmacokinetic and pharmacodynamic comparative studies and phase 3 studies to demonstrate biosimilar equivalency in patients for at least 1 indication of the originator product, investigators said.
Prior confirmatory studies have evaluated the biosimilarity of Ogivri and Herceptin in the metastatic HER2+ setting. In this study, investigators sought to elucidate biosimilar equivalence in the neoadjuvant, or early breast cancer (EBC), setting.
The study enrolled patients (N = 136; 56% originator, 43% biosimilar) treated with trastuzumab originator from November 2018 to October 2019 and the biosimilar from December 2019 to September 2020. There was no crossover between products. Investigators used logistic regression to control for factors that might affect pCR in either cohort, such as biosimilar or originator agent, age, tumor type, node positivity, tumor grade, hormone receptor status, treatment with chemotherapy, and whether chemotherapy treatment was completed.
Based on the logistic regression model, investigators saw no significant difference in pCR odds for patients treated with biosimilar vs originator (odds ratio [OR], 1.1; 95% CI, 0.5-2.4; P = .85). However, there was a statistically insignificant lower likelihood of pCR in patients with anthracycline use (OR, 0.72; 95% CI, 0.3-1.6; P = .417).
Investigators observed no significant differences in baseline characteristics among patients except the proportion of those with node negative results: 39%, biosimilar; 14.3%, originator (P = .001). For patients treated with biosimilar vs originator, pCR was a nonstatistically significant 35.6% vs 40.3%, respectively (P = .598).
“pCR rates were similar for patients treated with [Ogivri] compared with [Herceptin] in our real-world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials,” the authors concluded.
Reference
Yang C, Khwaja R, King K, et al. Trastuzumab-dkst versus trastuzumab: real-world pCR rates in patients with HER2+ breast cancer treated with neoadjuvant chemotherapy plus trastuzumab from Alberta, Canada. Presented at: ASCO 2021; June 3-7, 2021. Abstract e12569.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
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.