December 5th 2024
Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions.
November 27th 2024
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.
EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor
September 27th 2023With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.
Regulatory Updates From Around the Globe Provide Hope for Biosimilars
September 9th 2023An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
Sintilimab Plus Bevacizumab Biosimilar vs Avastin Is Cost-Effective in HCC
August 8th 2023A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.
Despite Global Increase in Amjevita Sales, US Sales Dropped 63%
August 5th 2023Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.
Abstracts Highlight Growing Comfortability With Trastuzumab Biosimilars in Breast Cancer
July 31st 2023Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time.
Samsung Bioepis Report Proves Lower Biosimilar Prices Correlate With Greater Market Share
July 19th 2023The second edition of Samsung Bioepis’ Biosimilar Market Report shows strong correlation between biosimilar usage and decreased drug prices, proving that biosimilars are delivering on the promise of savings and price erosion.
Dose Rounding Can Reduce Drug Waste Costs Associated With Reference, Biosimilar Bevacizumab
June 19th 2023Implementing strategies, such as dose rounding, can offset the impact of drug waste and reduce the total cost of care for value-based programs, according to a recent study of practices participating in the Oncology Care Model.
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.
Long-term Phase 3 Results Show Similar Efficacy, Cardiac Safety of SB3 vs Herceptin
May 6th 2023The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.
Despite Concerns Over Extrapolation, Bevacizumab Biosimilars Are Widely Used in mCRC
May 3rd 2023A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.
Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval
April 26th 2023Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.
Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars
April 19th 2023A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
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).
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.
Review: 15 Years of Real-world Data Demonstrates Safety of Epoetin Alfa Biosimilar HX575
March 4th 2023Authors 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.
FDA Issues CRL for Biocon Biologics, Viatris Avastin Biosimilar
February 14th 2023Biocon Biologics and its partner Viatris received a complete response letter (CRL) for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.