March 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.
FDA Issues CRL for Biocon Biologics, Viatris Avastin BiosimilarFebruary 14th 2023
Biocon 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.
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.
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.
Global Use of Medicines Report Predicts Biosimilars Will Save $290 Billion by 2027January 25th 2023
IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.
Phase 3 Study Finds Bioequivalence Between Celltrion Bevacizumab Biosimilar, Avastin for NSCLCJanuary 21st 2023
Celltrion Healthcare’s candidate bevacizumab biosimilar CT-P16 demonstrated equivalent efficacy, safety, and immunogenicity to Avastin (reference bevacizumab), in a phase 3 clinical trial in patients with non–small cell lung cancer (NSCLC).
Amneal, Kashiv Launch Filgrastim Biosimilar, ReleukoNovember 29th 2022
After receiving FDA approval in February 2022, Amneal Pharmaeuticals and Kashiv Biosciences launched Releuko (filgrastim-ayow) on the US market, making it the fourth biosimilar referencing Neupogen to be commercially available to Americans.
Administration for Pegfilgrastim Biosimilars Should Minimize Clinic Visits, Consider Patients’ PreferencesNovember 19th 2022
A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that providers should consider the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.
Biosimilar Check-in: PBM to Cover Adalimumab Biosimilars; World’s First Denosumab Biosimilar; Organon Launches in CanadaNovember 17th 2022
Organon Canada launches 2 biosimilars referencing Avastin (bevacizumab) and Herceptin (trastuzumab), China became the first country to approve a denosumab biosimilar, and Optum Rx, a large pharmacy benefit manager (PBM), said that it will add adalimumab biosimilars to formulary.
Meta-analysis Confirms Biosimilarity Between Bevacizumab Biosimilars, Avastin in NSCLC, Colorectal CancerNovember 12th 2022
The efficacy and safety of bevacizumab biosimilars in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) is comparable with the reference product (Avastin) and each other, according to a meta-analysis.
Dr Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar MarketNovember 9th 2022
Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
AMCP Nexus Abstracts Investigate Adoption, Budget Impact of BiosimilarsNovember 8th 2022
Abstracts presented at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting explored the adoption of infliximab biosimilars, utilization patterns of bevacizumab biosimilars in ophthalmology and oncology settings, and the budget impact of transferring patients to a natalizumab biosimilar from the originator.
Overview of Trastuzumab Biosimilars in HER2-Positive Breast CancerOctober 29th 2022
Authors of a systematic review summarized the results of 21 published studies on the efficacy, safety, and cost-benefit ratio of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Trastuzumab Biosimilar Found Safe, Effective in Pretreated HER2-Positive Breast CancerOctober 15th 2022
A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
Eye on Pharma: 2 US Launches, an EMA Filing, and Denosumab ResultsOctober 6th 2022
Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Amneal Pharmaceuticals filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.
Biosimilars Oncology Roundup: September 2022October 1st 2022
In addition to our month-long series preparing for the 2023 introduction of adalimumab biosimilars, September featured a number of updates for oncology biosimilars, including 2 FDA approvals and the withdrawal of a European application.
Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab ApplicationSeptember 29th 2022
Health Canada approved Lupin Limited’s Rymti, the third etanercept biosimilar to be granted regulatory approval in the country. Meanwhile, Prestige Biopharma announced that it withdrew its European application for its trastuzumab biosimilar.
Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market EntrySeptember 26th 2022
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, chronicles how drug prices as a result of biosimilar competition has evolved over time and what factors may contribute the most to price erosion.
Oncology, Ophthalmology Biosimilars Progress in EuropeSeptember 19th 2022
As the United Kingdom adds another oncology biosimilar to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.
EC Grants Celltrion Avastin Biosimilar Marketing AuthorizationAugust 20th 2022
The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.
Companies Clinch Deals for Global Biosimilar CommercializationJuly 26th 2022
Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.
Alvotech to Launch Pharmacokinetics Study for Denosumab BiosimilarJuly 20th 2022
The biosimilar candidate would reference Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer.