December 16, 2020
A recent article outlines challenges that remain regarding the regulatory evaluation of biosimilars and offers potential solutions for the future.
December 11, 2020
A recent policy review identifies factors that prevent the effective launch of oncology biosimilars.
October 02, 2020
Biosimilar rituximab and biosimilar trastuzumab are associated with acceptable safety profiles among patients with cancer treated in the real-world clinical setting, according to a recent study.
September 21, 2020
A position paper released by the American College of Physicians made concrete policy reform suggestions for prescription drug competition, calling for a realignment of incentives and rewards for true innovation.
August 25, 2020
True or False: Chemotherapy-induced febrile neutropenia prophylaxis with biosimilar pegfilgrastim-bmez increases the value of cancer care.
July 29, 2020
NCCN and Pfizer announce collaboration to offer a new grant opportunity supporting the development and validation of ongoing approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology.
July 24, 2020
Chemotherapy-induced febrile neutropenia prophylaxis with pegfilgrastim-bmez increases the value of cancer care and generates significant cost-savings over the reference product, improving access to care for these patients.
July 08, 2020
Patients with HER2-positive advanced gastric cancer who are treated with a first-line biosimilar-containing triplet regimen may experience clinically meaningful benefit regardless of PD-L1 status, according to a recent study.
June 26, 2020
A cross-sectional survey showed that, while many oncology providers believe biosimilar products to be safe and effective, they may be hesitant to prescribe these products for multiple reasons.
June 19, 2020
Simulation modeling demonstrated that prophylaxis of chemotherapy-induced febrile neutropenia with a supportive care biosimilar can lead to significant cost savings.
June 12, 2020
A study that tracked average reimbursement by CMS for a supportive care biosimilar may have a significant impact on an OCM practice’s performance.
April 30, 2020
Results of a recent survey have led to the identification of various biosimilar learning needs and challenges faced in obtaining biosimilar education among oncology pharmacists.
April 16, 2020
A recent analysis evaluated the potential capability of the Biologics and Biosimilars Collective Intelligence Consortium Distributed Research Network for future study of biosimilar use and safety.
April 03, 2020
A study at a large academic medical center shed light on a successful biosimilar adoption program, cost-savings associated with transitioning patients to the biosimilar, and real-world outcomes of those who transitioned.
March 26, 2020
The US Food and Drug Administration is set to approve biosimilar products through a new regulatory pathway that will help foster competition between biologics.
February 13, 2020
Gary H Lyman, MD, MPH, FASCO, FRCP, Fred Hutchinson Cancer Research Center, discusses biosimilar updates in the US market, interchangeability designations, and use in oncology clinical pathways.
December 31, 2019
Gary Lyman, MD, MPH, details why it may take 8-12 years to prove that biosimilars should be trusted in everyday clinical practice and touches on issues of granting extrapolation.
September 11, 2019
Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, explains why oncology biosimilar uptake in the US has been a lengthy process and whether these products will be viable options for payer-based and provider-based clinical pathways in the future.
July 25, 2019
Scott Vogel, partner and PBM executive, Confidio, recently spoke about the many challenges facing biosimilar uptake as they come to the market and where the market might be heading.
July 23, 2019
Biosimilars to treat colorectal and breast cancers, among other indications, are the first anticancer biosimilars to reach the market, according to a new report.
July 02, 2019
Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, president of ACCC, discusses his goals for his presidency, the common ground between standardized care and patient-centered care, and the role of biosimilars in treating patients with cancer in the immediate future.
June 18, 2019
Published data presented at the ASCO Annual Meeting highlighted the post-approval safety of a biosimilar product for DLBCL.
June 07, 2019
An ASCO Annual Meeting presentation showed the long-term safety and efficacy data of the phase III HERITAGE trial comparing biosimilar trastuzumab-dkst monotherapy vs trastuzumab monotherapy.
May 22, 2019
A diverse panel at the ISPOR annual meeting considered biosimilars and interchangeables from a regulatory and industry perspective, addressing some of the key hurdles and projections of health care savings due to biosimilar uptake in the next 5 years.
May 14, 2019
The FDA has provided final guidance on how biosimilars can achieve interchangeable status, which allows biosimilars to be substituted for their reference biologic without a prescriber intervening.
April 30, 2019
In real-life practice in patients with NSCLC, a biosimilar product for chemotherapy-induced neutropenia demonstrates similar effectiveness and safety to that of the reference drug.
Guideline Updates
April 22, 2019
ASCO and ASH have issued an updated practice guideline on the use of erythropoiesis-stimulating agent biosimilars for patients with chemotherapy-associated anemia.
April 15, 2019
Gary H Lyman, MD, MPH, provided an update on new developments in biosimilars, forecasting how biosimilars may impact cancer costs and treatment in the near future.
FDA Approval
March 12, 2019
The FDA has granted approval to a biosimilar product for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
March 06, 2019
Industry groups are asking the FDA to dispel “untruthful or misleading” information on biosimilar products.
February 19, 2019
Doug Long, VP of industry relations at IQVIA, provided an update on trends in the generic and biosimilars market in the US and across the world at a recent conference.
February 01, 2019
Approximately 74% of survey respondents could not give a satisfactory definition of biosimilars, and 40.3% considered biosimilars to be the same as generic drugs.
January 16, 2019
A systematic review found that limited knowledge, low prescribing comfort, and safety and efficacy concerns are the main deterrents for biosimilar use among health care providers.
November 13, 2018
Colony-stimulating growth factors biosimilars filgrastim-sndz and filgrastim-tbo are comparable in terms of safety and efficacy to the reference drug, researchers say.
September 12, 2018
Winston Wong, PharmD, breaks down the ASCO position statement on the utilization of biosimilars in oncology and ways in which the anticipated cost-savings may be achieved.
August 30, 2018
Gary Lyman, MD, MPH, explains the process of bringing oncology biosimilars to market and their potential uptake in clinical practice as well as pathways.
August 16, 2018
A budget impact analysis estimates the effective annual plan per-patient drug costs of a supportive care biologic and biosimilar to decrease significantly with respect to the original therapy.
May 24, 2018
The results from a randomized controlled trial were compared with a real-world cohort for the safety and efficacy of a biosimilar to treat chemotherapy-induced neutropenia in patients with breast…
May 02, 2018
A comparative effectiveness study examined clinical outcomes and costs after treatment with a febrile neutropenia therapy vs a biosimilar for patients with non-myeloid cancer undergoing chemotherapy.
April 16, 2018
Robert M Rifkin, MD, FACP, gave an update on the basics, education, and reimbursement of biosimilars, stating that “this will be a huge year” for the the copycat biologics in the United States.
February 16, 2018
A recent study found that a biosimilar provides improved outcomes without increased risk of toxicity for patients with DLBCL and treatment-induced neutropenia.
September 20, 2017
The Centers for Medicare and Medicaid Services are being urged to make changes that could improve savings for patients and health care payers, as well as expand patient access to biosimilars.
Clinical Pathways GPS
December 14, 2015
A flood of biosimilars is expected to be released in the coming years, Drs. Stefanacci and Guerin discuss how these new drugs will affect the development of new and current clinical pathways.