Access 2023: Mark Cuban Teases Adding Biosimilars to Online Pharmacy, Champions GenericsFebruary 15th 2023
At the annual meeting of the Association for Accessible Medicines (Access 2023), Shark Tank’s Mark Cuban explained his dedication to and the inner workings of his online pharmacy that provides generic drugs to patients for significantly lower prices than traditional pharmacies.
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.
What Will Be the Major Drivers Behind IQVIA's Predicted Biosimilars Uptake, Savings?February 14th 2023
Adalimumab and ustekinumab biosimilars aren't the only factors that will drive biosimilar adoption and savings through 2023, according to Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.
Sandoz' Dr Sonia Oskouei Predicts How Adalimumab Biosimilars Can Help Biosimilar Uptake OverallFebruary 12th 2023
Sonia 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.
IQVIA: US Spending on Biosimilars to Reach $129 Billion Over Next 5 YearsFebruary 9th 2023
IQVIA’s Biosimilars in the United States 2023-2027 report found that while the US biologics market has grown 12.5% annually over the last 5 years, spending on biosimilars is growing and is expected to reach $129 billion by 2027.
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.
High Treatment Retention Following Biosimilar-to-Biosimilar Switch in DenmarkFebruary 4th 2023
A 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.
FDA Updates Biosimilar Regulatory Research Program With RoadmapFebruary 2nd 2023
The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.
Biosimilar Rheumatology Roundup: January 2023February 1st 2023
This year started off with a bang for rheumatology biosimilars, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).
Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology BiosimilarsJanuary 29th 2023
On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.
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.
IRA Insulin Cap Could Have Saved Medicare Beneficiaries Millions in 2020January 24th 2023
A new report from HHS has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.
Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab ResultsJanuary 22nd 2023
Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.
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).
Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022January 19th 2023
Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.
Study Compares Uptake, Prices of Biosimilars in US vs 2 European CountriesJanuary 12th 2023
A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.
Biosimilar Business Recap: Coherus Acquires Aflibercept; CRL for Biocon Biologics; Biosimilar Insulin UpdatesJanuary 11th 2023
Coherus Biosciences has acquired an aflibercept biosimilar; the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar; Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.