June 3rd 2023
Alvotech and Advanz Pharma extend their partnership to commercialize 5 biosimilar candidates across Europe.
Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the IndustryMay 11th 2023
The 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 AdoptionMay 10th 2023
In 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.
Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo EffectApril 27th 2023
Nonmedical 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.
Multiple Infliximab Biosimilar Switches Appear Safe, Effective for Patients With IBDApril 20th 2023
A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.
FDA Issues Another CRL for Alvotech’s Adalimumab BiosimilarApril 14th 2023
In 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.
Eye on Pharma: EU Approves High-Concentration Adalimumab Biosimilar; FDA Accepts BLA for HLX02April 6th 2023
The 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 LowApril 3rd 2023
Although 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 PolicyMarch 30th 2023
Yukon, 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.
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.
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.
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.
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.
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.
Patients With RA, IBD Trust Specialists’ Biologic and Biosimilar RecommendationsFebruary 24th 2023
Patients 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 BiosimilarsFebruary 23rd 2023
In 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.
Biosimilar Business Recap: New Ustekinumab Partnership; Similis Bio Biosimilar Programs; Celltrion Japan LaunchFebruary 23rd 2023
Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.
Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab StudyFebruary 8th 2023
Formycon 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 BiologicsFebruary 7th 2023
Vizient’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.
Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy’s Completes StudyJanuary 26th 2023
Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.
FDA Accepts BLA for Alvotech Ustekinumab BiosimilarJanuary 6th 2023
Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.
TNF Inhibitor Biosimilar Use in FranceDecember 31st 2022
A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the key drivers for biosimilar use to improve biosimilar uptake in France.
Eye on Pharma: Janssen Sues Amgen, Express Scripts to Cover Adalimumab BiosimilarDecember 19th 2022
Janssen filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.