Results for 'biologics in cancer treatment'
Jorge J. García, Luis E. Raez, Daniel Rosas
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
Biosimilars, interchangeability, extrapolation, immunogenicity
Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared to traditional chemotherapy. The cost of biologic drugs is high, leading to increased healthcare expenses. This mirror…
Aug 3rd • 10 mins read
Mark Verrill, Paul Declerck, Sibylle Loibl, Jake Lee & Javier Cortes
The rise of oncology biosimilars: from process to promise
biologic, biosimilar, breast cancer, SB3, trastuzumab
Biosimilars are biologic products that are highly similar to the approved originator molecule, with no clinically meaningful differences. They are expected to play a key role in cancer treatment by reducing costs and improving access. Regulatory bodies use robust mechanisms for approval, involvi…
Aug 23rd • 18 mins read
YuQian Liu, PharmD
Uptake of Oncology Biosimilars: Managed Care Strategies to Improve Value-Based Care Systems
biosimilars in oncology, cost-effective cancer care, healthcare education, bioequivalence studies, biosimilar adoption, cancer treatment protocols
Biosimilars offer a cost-effective alternative in oncology, expanding access to cancer care, but their utilization is inconsistent due to varying perceptions and knowledge among stakeholders. Increasing the adoption of biosimilars requires improved education and understanding among healthcare pro…
Jul 7th • 25 mins read
Rinda Devi Bachu, Mariam Abou-Dahech, Swapnaa Balaji, Sai H. S. Boddu, Samson Amos, Vishal Singh, R. Jayachandra Babu, Amit K. Tiwari
Oncology biosimilars: New developments and future directions
biologics in cancer treatment, biosimilars development, high cost of biologics, healthcare system burden, biosimilars safety, regulatory guidelines for biosimilars, immunogenicity concerns, pharmacoeconomics of biosimilars
Biologics are essential in cancer treatment as both therapeutic and supportive care agents, but they are expensive and require extensive testing to ensure safety. The high cost of developing and manufacturing biologics can be a burden on healthcare systems, limiting patient access to necessary tr…
Nov 25th • 30 mins read
John Hair, Thomas Maryon, and Cristian Lieneck
Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption
oncology, cancer, biosimilar, barriers, access, obstacles
Biosimilars are biologic medical products that are almost identical to original biologics but are produced by different companies. They are safe, effective, and can reduce costs for insurers and patients. Despite the benefits, barriers exist for oncologists and cancer centers in prescribing biosi…
Oct 27th • 30 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
biologics, external validity, FDA, biosimilars, trastuzumab
Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…
Apr 6th • 2 mins read
Qiyou Wu, Zhiwei Lian, Xin Wang, Hanchao Cheng, Jing Sun, Hui Yu, Gong Zhang, Fan Wu, Jian Liu and Chuanben Chen
Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China
biosimilar, breast cancer, uptake, physician, patient
In 2021, the trastuzumab biosimilar entered clinical use in the research setting with less than 20% uptake in China, significantly lower than in the EU. Older patients are more likely to adopt biosimilars due to price sensitivity and financial concerns. Only 11.3% of patients switched from …
Jan 12th • 13 mins read
Carina Dolan, PharmD, BCOP
Opportunities and challenges in biosimilar uptake in oncology
Trastuzumab, Rituximab, biosimiliar agents, emerging agents, cetuximab, bevacizumab, clinical trials, biosimiliars
The U.S. has 10 approved biosimilars, including 3 for oncology, with many more in development, potentially increasing access to expensive biologics. Acceptance by healthcare providers and patients requires extensive education, resolving concerns about immunogenicity, and ensuring interchangeability.…
Jun 26th • 7 mins read
Kirsten B Goldberg, Gideon M Blumenthal, Amy E McKee and Richard Pazdur
The FDA Oncology Center of Excellence and Precision Medicine
Biomarkers, drugs, hematology, medicine, oncology, precision medicine, regulation
The FDA is exploring real-world evidence to enhance understanding of the long-term safety and efficacy of oncology drugs. Initiatives like the Information Exchange and Data Transformation initiative are building infrastructure for big-data analytics. Additionally, patient-focused programs aim to inc…
Nov 6th • 3 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
John Devin Peipert, PhD, Karen Kaiser, PhD, Sheetal Kircher, MD, George J. Greene, PhD, Sara Shaunfield, PhD, Katherina Hauner, PhD, David Cella, PhD, and Daniel K. Mroczek, PhD
Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
oncologist, biosimilars, ASCO, FDA, RSP
Most oncologists (88%) treated patients with biosimilars, and 63% reported that biosimilars were required at their institutions. Approximately half (52%) correctly identified that biosimilars are not the same as generic medicines. Common barriers to biosimilar use included concerns abou…
Jan 9th • 9 mins read
Marc Thill, Nicholas Thatcher, Vladimir Hanes & Gary H. Lyman
Biosimilars: what the oncologist should know
biosimilars, extrapolation, monoclonal antibodies, oncologic biosimilars
As originator biologic medicines lose patent protection, biopharmaceutical companies are developing biosimilars. Biosimilars are similar versions of costly and complex therapies aimed at providing more affordable treatment options. Many biosimilars are now approved worldwide, with several m…
Dec 18th • 25 mins read