May 1st 2024
April brought 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Survey: Moderate Acceptance of Anti-TNF Biosimilars Among Patients With Immune-Mediated Conditions
October 24th 2021Patients with and without experience with tumor necrosis factor (TNF)–blocker biologics have incomplete knowledge of biosimilars for these agents, according to findings presented at the Academy of Managed Care Pharmacy 2021 Nexus meeting.
Preferred Status for Semglee Will Test Value Proposition of Insulin Biosimilars
October 20th 2021Hopes that insulin biosimilars can improve access and affordability will be tested by Express Scripts’ plan to give preferred formulary status to Semglee, a long-acting insulin that is interchangeable with Lantus.
Gary Lyman, MD, MPH, Explores the Progress With Oncology Biosimilars
October 17th 2021Oncology biosimilars are broadly in use for good reason: They're absolutely vital for cost reduction and access, but efforts are needed to promote uptake of these agents, says Gary Lyman, MD, MPH, in this interview.
Dose Adjustment, Infusion Interval Changes Hold Value for Patients With AS Treated With CT-P13
October 14th 2021Investigators said the RAAS study filled in missing information on the value of dose modulations and infusion interval changes for patients with ankylosing spondylitis (AS) treated with CT-P13 (Remsima, Inflectra).
Canadian Experts Offer Switching Guidance for Biosimilars in Rheumatology
October 5th 2021Preventing 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.
Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I
September 28th 2021Adrian 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.
Cardinal Health Biosimilars Expert Discusses Dynamics of Byooviz Launch
September 24th 2021The 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
September 23rd 2021The 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.
Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy
September 22nd 2021The 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.
Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO
September 20th 2021Investigators 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.
Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill
September 17th 2021Alvotech 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.
Samsung Bioepis Reports Long-term Ontruzant Findings for HER2-Positive Breast Cancer
September 14th 2021The 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
September 14th 2021The 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.