How Community Oncologists Can Break Down Biosimilar Adoption BarriersMarch 19th 2023
On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.
Retrospective Study Supports Safety of Anti-TNF Biosimilars During PregnancyMarch 18th 2023
More and more women are becoming pregnant while on anti-tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.
CVS Predicts Interchangeability Won’t Drive Adalimumab Biosimilar AdoptionMarch 15th 2023
In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.
Contributor: FDA Introduces New AI-Based Safety Evaluation Tool to Help Demonstrate BiosimilarityMarch 14th 2023
The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.
Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars Role Within Big PharmaMarch 13th 2023
Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
IQVIA's Michael Kleinrock Shares Why Smaller Manufacturers Are Investing in Biosimilar DevelopmentMarch 12th 2023
Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.
Policy Recommendations for Improving Biosimilar Uptake in BelgiumMarch 11th 2023
Increasing the use of biosimilars in Belgium will require realigning financial incentives and providing more information to medical professionals, according to authors of a study that proposed policy recommendations.
Phase 3 Study Demonstrates Comparable Safety, Efficacy Between Ranibizumab Biosimilar, Lucentis for nAMDMarch 10th 2023
Comparable safety and efficacy were found between biosimilar FYB201 compared with reference ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD).
Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials BeginMarch 9th 2023
The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.
White Paper Argues Increased Competition Will Improve Biosimilar Uptake, SavingsMarch 8th 2023
A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.
Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 2March 7th 2023
In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.
FDA Approves Autoinjector Version of Neulasta BiosimilarMarch 6th 2023
The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.
Celltrion Publishes Data on Maintenance Therapy Using Infliximab BiobetterMarch 6th 2023
At the European Crohn’s and Colitis Organisation congress, Celltrion Healthcare shared positive safety and efficacy data on maintenance therapy including its infliximab biobetter allowing for subcutaneous administration, Remsima SC.
Biosimilars Gastroenterology Roundup for February 2023—Podcast EditionMarch 5th 2023
On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.
Review: 15 Years of Real-world Data Demonstrates Safety of Epoetin Alfa Biosimilar HX575March 4th 2023
Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.
Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MSMarch 3rd 2023
Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).
Lilly Plans to Launch Insulin Biosimilar at 78% Discount to LantusMarch 2nd 2023
As Eli Lilly and Company announces that it will slash prices for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).
Biosimilars Gastroenterology Roundup: February 2023March 1st 2023
As a new wave of biosimilars to treat inflammatory bowel disease— an umbrella term for Crohn disease and ulcerative colitis—enter the US market, a lot of clinical and policy news regarding adalimumab and infliximab biosimilars emerged throughout the month of February.
Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 1February 28th 2023
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, details how biosimilar guidelines from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.
ACR Supports Affordable Treatments, Use of Biosimilars Following Rigorous Approval ProcessFebruary 27th 2023
The American College of Rheumatology (ACR) steadfastly supports the availability of safe and effective treatments for patients at the lowest cost possible, and underscores the necessity of scientific rigor for biosimilar use and approval.
BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLsFebruary 27th 2023
Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.
On the Come Up: What Vizient’s Report Says About Inflation and BiosimilarsFebruary 26th 2023
On this episode of Not So Different, Vizient’s Carina Dolan, PharmD, MS, BCOP, expounds on some of the results from Vizient’s recent edition of its Pharmacy Market Outlook Report, including how inflation could influence biosimilar utilization.
Sintilimab Plus Bevacizumab Biosimilar Therapy Associated With Better Outcomes, Higher Costs Than LenvatinibFebruary 25th 2023
According to the authors of a cost-effectiveness analysis of treatments for hepatocellular carcinoma (HCC) in China, sintilimab plus a bevacizumab biosimilar could improve quality of life for patients, but at a higher cost than lenvatinib.