Nabil Saba, MD, a medical oncologist and immunotherapy specialist in the treatment of head and neck cancer at Emory Healthcare and the Winship Cancer Institute, explained how the eventual introduction of biosimilars for Opdivo (nivolumab) and Keytruda (pembrolizuamb) will help patients with head and neck cancer.
This interview was filmed at The American Journal of Managed Care®'s Institute of Value-Based Medicine® event in Atlanta, Georgia.
Transcript
Several companies are currently working on developing nivolumab and pembrolizumab biosimilars1,2,3. How do you expect these products to help in the fight to end OPSCC (oropharyngeal squamous cell carcinoma) if they get approved and enter the market?
Saba: Great question. Nivolumab [Opdivo] and pembrolizumab [Keytruda] are both FDA-approved now for treatment of advanced metastatic head and neck cancer, including HPV [human papillomavirus]–related head and neck cancer, [such as OPSCC]. And by the way, this continues to be a big challenge as far as treatment for metastatic disease and when we talk about the necessity for vaccination, we really have to look at the other end of the spectrum when patients come to our clinic with advanced metastatic head and neck cancer and have very few options to get to get therapy.
Thankfully, we're having some improvement in the availablility of treatments for these patients. So, to remind people nivolumab and pembrolizumab are both PD [programmed death]–1 inhibitors; therefore, they are immunotherapeutic drugs. They're not really killing cancer cells by poisoning these cancer cells like chemotherapy or radiation. They are really working with a person's own immune system to fight off these cancers, and HPV-related head and neck cancer does respond fairly well to these agents.
I think the question of biosimilars is a very interesting question overall. And I think that if these biosimilar agents become approved, I think that will open the door for treating more patients, because cost of these currently approved drugs is really prohibitive in many instances for getting them administered to every segment of the population. And I think because biosimilars reduce the cost, basically, they will allow us to focus on reducing the cost and getting the rest of the of the saved cost, essentially, into other functions or into other missions—perhaps treating more patients, perhaps prevention, perhaps vaccination.
When you reduce the cost of these drugs, there's a big advantage, I think, at the society level overall, because you're able to basically funnel the saved money essentially to fund other functions that are very important. So, I look forward to actually having these [biosimilar] drugs down the line and to be approved, and I think we are starting to see this in several segments of health care and oncology.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
2 Commerce Drive
Cranbury, NJ 08512