April 20th 2024
In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry
May 11th 2023The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.
Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption
May 10th 2023In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.
RWE: Rituximab Biosimilar GP2013 Effective in Patients With RA After Switching From Originator
May 8th 2023In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.
Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo Effect
April 27th 2023Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.
FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar
April 14th 2023In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.
Real-world Data Show Interchangeability of Rituximab Biosimilar
April 11th 2023A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was safe for patients and did not result in a change in adverse events.
Eye on Pharma: EU Approves High-Concentration Adalimumab Biosimilar; FDA Accepts BLA for HLX02
April 6th 2023The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).
Spherix Global Insights: Despite High Awareness, Provider Comfort With Adalimumab Biosimilars Is Low
April 3rd 2023Although rheumatologists, dermatologists, and gastroenterologists rated their awareness of adalimumab biosimilars as high, a significant proportion of each group reported that they were not confident prescribing a biosimilar over the originator.
Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy
March 30th 2023Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.
Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab
March 27th 2023Posters 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).
A Long Time Coming: Dr Sophia Humphreys Details What’s Coming Down the Biosimilar Pipeline
March 23rd 2023In 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.
Retrospective Study Supports Safety of Anti-TNF Biosimilars During Pregnancy
March 18th 2023More 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 Adoption
March 15th 2023In 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.
Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin
March 9th 2023The 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.
ACR Supports Affordable Treatments, Use of Biosimilars Following Rigorous Approval Process
February 27th 2023The 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.
Patients With RA, IBD Trust Specialists’ Biologic and Biosimilar Recommendations
February 24th 2023Patients with rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) have similar positive attitudes towards biologics and both trust their specialists’ recommendations, according to a recent survey conducted in Australia.
Report: Over 60% of Providers Plan to Only Prescribe Interchangeable Adalimumab Biosimilars
February 23rd 2023In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said they would only want to prescribe adalimumab biosimilars with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.
Study: Higher Adherence Rates Among Users of the Remicade vs Infliximab Biosimilars
February 18th 2023An analysis of US claims data found that prevalent (as of 2017) users of the infliximab reference product (Remicade) had the highest adherence rates compared to naïve originator users, prevalent biosimilar users, and naïve biosimilar users over 18 months of follow-up.
Sandoz' Dr Sonia Oskouei Predicts How Adalimumab Biosimilars Can Help Biosimilar Uptake Overall
February 12th 2023Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, foreshadows how the US market introduction of adalimumab biosimilars could influence future biosimilar entrances and discusses why educational efforts need to be tailored to different specialties and stakeholders.
Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab Study
February 8th 2023Formycon shared positive data on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.
Vizient Report Predicts Over 3% Inflation Rate for Biologics
February 7th 2023Vizient’s Pharmacy Market Outlook report examined the impact that factors, such as the COVID-19 pandemic and the US market introduction of adalimumab biosimilars, will have on drug prices and the utilization of lower-cost biologics.
High Treatment Retention Following Biosimilar-to-Biosimilar Switch in Denmark
February 4th 2023A real-world study assessing the aftermath of Denmark implementing a nationwide mandatory switch from one infliximab to another found strong treatment retention rates, demonstrating the safety and tolerability of biosimilar-to-biosimilar switching.