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ODAC Recommends First Biosimliar for Approval to the FDA
The investigational drug by Sandoz, filgrastim, a biological similar to Amgen's Neupogen, is already approved for use in more than 40 countries worldwide.
Sandoz, a Novartis company, announced today that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the reference product's (Amgen's NEUPOGEN(R) ) label.
"We are pleased with the ODAC's recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing," said Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. "We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US."
Link to the Sandoz press release: http://bit.ly/1BMMIs0
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Uniting to Support Patients With Cancer Beyond Treatment
November 17th 2024Kasey Bond, MPH, of Perlmutter Cancer Center at NYU Langone Health, speaks to why it’s vital to keep patients at the center of all strategic partnerships between academic institutions and community-based oncology practices.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Bridging Cancer Care Gaps and Overcoming Medical Mistrust
November 13th 2024In this clip from our interview with Oscar B. Lahoud, MD, cochair of our Institute for Value-Based Medicine® evening hosted with NYU Langone Health, he addressed medical mistrust in underrepresented communities.
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How English- and Spanish-Preferring Patients With Cancer Decide on Emergency Care
November 13th 2024Care delivery innovations to help patients with cancer avoid emergency department visits are underused. The authors interviewed English- and Spanish-preferring patients at 2 diverse health systems to understand why.
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