December 4th 2023
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
December 2nd 2023
A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
November 28th 2023
Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
November 23rd 2023
The legal and common uses of “interchangeability” continue to be conflated.
November 20th 2023
Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.
Canadian Experts Offer Switching Guidance for Biosimilars in Rheumatology
Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment guidance document.
Remsima Delivers Positive Results in IBD Switching Study
Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.
Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I
Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets.
FDA Tweaks Biosimilar Application Review Program
Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.
Cardinal Health Biosimilars Expert Discusses Dynamics of Byooviz Launch
The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.
AAO Reacts to Ranibizumab Biosimilar Approval
The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.
Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings
In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.
Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy
The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.
FDA Approves First Ophthalmology Biosimilar: A Ranibizumab
Byooviz (ranibizumab) was approved for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.
Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO
Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.
Study: Zarxio More Costly Than Neupogen in Outpatient Hospital Setting
According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.
Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill
Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.
Biocad's BCD-021 Bevacizumab Biosimilar Demonstrates Equivalence in NSCLC
BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).
MIL60 Bevacizumab Biosimilar Candidate Demonstrates Equivalence in NSCLC
MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.
Samsung Bioepis Reports Long-term Ontruzant Findings for HER2-Positive Breast Cancer
The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.
ASBM Appoints New Chair in Battle Against Nonmedical Switching
The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.
BIO Attorneys Address Patent Thicket Misconceptions
In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.
Samsung Bioepis Executive Comments on Kaiser Permanente’s Biosimilar Success
Kaiser Permanente got biosimilars into circulation by building physician confidence, a strategy that a Samsung Bioepis executive says should be employed more widely.
Dr Gary Lyman: Are Interchangeability Designations for Biosimilars Meaningful?
Gary Lyman, MD, MPH, an oncologist and hematologist, explains that biosimilar substitution in the absence of interchangeability designations is widespread and not without clinical merit.
Meta-analysis of Sandoz Pegfilgrastim PK/PD Studies Supports Biosimilarity
A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.
Biosimilars Roundup: Policy and Business Developments Signify a Busy August
Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an active time for these lower-cost biologics.
Report: Physician-Patient Education Can Improve Biosimilar Acceptance
Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.
Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars
Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.
CVS Juggles Biosimilar Options on Its Formulary
CVS Caremark has reordered its list of preferred therapeutics, adjusting the emphasis on biosimilars, and demonstrating that preferential status can change at any time.
IPC Guidance Is Issued on Safety of Biosimilar Switching in Psoriasis
The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.
Study: Biosimilar rhGH Well Tolerated and Effective in Turner Syndrome
A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.
Dr Gary Lyman: Formulary Placements and Physicians' Biosimilar Prescribing Patterns
Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how biosimilar placement on formularies affects physicians' willingness to prescribe these agents.
Opinion: A Modified 351(a) Licensing Pathway for Biosimilars
Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.
Rumors of HHS Biosimilars Coding Change Spark Concerns
Worries about what HHS will propose in its anticipated biologics pricing reform policy have been exacerbated by a rumored coding change.
Advocacy Groups Call for Zero Co-pay Policy on Biosimilars
A group of 16 advocacy groups are urging HHS to make zero co-pays for biologics a part of its prescription drug price reform program.
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