The Increasing Access to Biosimilars Act of 2023 Introduced to CongressMarch 29th 2023
The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.
Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference UstekinumabMarch 27th 2023
Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).
Real-world Studies Show Comparable Outcomes, Higher Discontinuation Rates Between Originators, Biosimilars in RAMarch 25th 2023
A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.
A Long Time Coming: Dr Sophia Humphreys Details What’s Coming Down the Biosimilar PipelineMarch 23rd 2023
In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.
Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar SwitchingMarch 22nd 2023
At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.
FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, HyrimozMarch 21st 2023
Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed WarnsMarch 21st 2023
At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?
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.