Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Biosimilar Oncology Roundup for November 2023—Podcast Edition
On this episode, we discuss the abundance of oncology news from November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.
Biosimilars Oncology Roundup: November 2023
The Center for Biosimilars® covered an abundance of oncology news during November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Dr Chelsee Jensen Discusses Pricing Strategies for Adalimumab Biosimilars
Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Global Biosimilars Week: Dr Fran Gregory Explores the Growing Oncology Biosimilar Space, Previews Future
Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, examines the evolution of the oncology biosimilar space in this special episode of Not So Different to close out Global Biosimilars Week 2023.
The Top 5 Biosimilar Articles for the Week of November 13
Here are the top 5 biosimilar articles for the week of November 13, 2023.
Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe
In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.
Part 2: French Study Finds Trastuzumab Biosimilar Program Could Generate Meaningful Savings
In part 2 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® explores a cost-effectiveness analysis evaluating the use of subcutaneous trastuzumab biosimilars to treat breast cancer in a French hospital setting.
Part 1: Oncology Biosimilars Offer Comparable Benefits to Originators at Lower Prices
In part 1 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® looks at a retrospective study comparing the clinical benefits, price changes, and uptake associated with oncology biosimilars in China.
Panelists Deliberate Strategies to Enhance Biosimilar Integration in Managed Care Spaces
At the recent Academy of Managed Care Pharmacy Nexus meeting, panelists discussed the impact of introducing biosimilars in new medical fields, emphasizing the need for more education and collaboration to ensure their smooth integration into health care systems.
Dr Ryan Haumschild Draws Link Between Biosimilars, Health Equity in Breast Cancer
Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, discusses the growth and continued challenges facing biosimilars used to treat breast cancer.
Public Payer in Poland Saves €243 Million by Using Biosimilar TNF Inhibitors
The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.
Real-World Data Confirm Safety, Efficacy of CT-P13 in Inflammatory Diseases
A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.
Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate
Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.
Denosumab Biosimilar Demonstrates Positive Safety Results in Chinese Study
A Chinese randomized study in healthy participants found comparable pharmacokinetic, pharmacodynamic, and safety profiles between LY01011, a denosumab biosimilar, and its originator (Xgeva).
Biosimilar Business Roundup for October 2023—Podcast Edition
On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
The Top 5 Biosimilar Articles for the Week of October 30
Here are the top 5 biosimilar articles for the week of October 30, 2023.
Physicians Agree on Safety of Biosimilars, Nonmedical Switching in IBD, Survey Says
An international survey found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.
FDA Approves First Stelara Biosimilar, Wezlana
The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation.
Biosimilars Business Roundup: October 2023
Between 3 regulatory approvals, 2 complete response letters, and new data and industry insights, October brought a number of business updates that have the potential to impact the entire US biosimilar industry.
Pegfilgrastim Biosimilar Proves Effective Against Neutropenia in Patients With Breast Cancer
A recent study found that a pegfilgrastim biosimilar was effective against chemotherapy-induced neutropenia and had comparable safety and efficacy profiles compared with the originator (Neulasta) in patients with breast cancer.
Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market
Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.
Commercial Biosimilar Coverage Is on the Rise, but Preferences Still Vary
A poster from AMCP Nexus quantifies trends in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still vary.
The Top 5 Biosimilar Articles for the Week of October 23
Here are the top 5 biosimilar articles for the week of October 23, 2023.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future
As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
Samsung 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.
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