Use of Biosimilar Growth Factor Increases in Supportive Cancer Care

MedicalResearch.com Interview with:

Abiy Agiro, PHD HealthCore Inc Wilmington, Delaware

Dr. Agiro

Abiy Agiro, PHD
HealthCore Inc
Wilmington, Delaware 

MedicalResearch.com: What is the background for this study?

Response: Biosimilar approval pathway, authorized in 2010 by the Biologics Price Competition and Innovation Act as part of the Affordable Care Act, aims to increase adoption of biosimilar products and generate significant cost savings to payers and patients alike. Biosimilar filgrastim, used to prevent febrile neutropenia, is one of the first biosimilars to be approved in the United States. A large scale, post-approval real-world analysis was needed that compares biosimilar filgrastim to the original drug for safety and efficacy.

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Herceptin Biosimilar CT-P6 Found Safe and Effective in Early Breast Cancer

MedicalResearch.com Interview with:

Prof Francisco J Esteva MD PhD</strong> Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center

Prof. Esteva

Prof Francisco J Esteva MD PhD
Director of the breast medical oncology program at Perlmutter Cancer Center.
NYU Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer.

In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial.

We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar.

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