Biogen, Samsung Report Third-Quarter Biosimilar Results
Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.
Henlius Inks Global Bevacizumab Biosimilar Distribution Deal
Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.
NeuClone's Ustekinimab Candidate Shines in Phase 1 Trial
Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.
CT-P10 and Reference Rituximab Evaluated in Primary Sjögren Syndrome
Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.
Avalere: Step Therapy May Exacerbate Patient, Payer Costs
An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.
ICER: Infliximab Is Highest in Cost-Effectiveness for UC
Reviewers found that costs of reference infliximab and its biosimilars make it the most cost-effective therapy for ulcerative colitis (UC) among targeted immune modulators.
Case Study: Dean Foods Attempts Savings via Specialty Carve-out
Before its acquisition this year, Dean Foods attempted a specialty drug carve-out to save with biosimilars and generics.
Roche Earnings Hit by Biosimilar Competition, COVID-19
Roche attributes a $3.83 billion reduction in sales to biosimilar competition.
The Top 5 Biosimilar Articles for the Week of October 12
Here are the top 5 biosimilar articles for the week of October 12, 2020.
Revance Reports Positive Findings for Potential Botox Competitor
DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.
Amgen 2020 Biosimilar Report Provides Market Share, ASP Info
Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.
Alexion, Celltrion Notch Product Development Gains
Alexion and Celltrion separately announce advances in their drug development and marketing efforts.
Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars
Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.
PIRG Files Amicus Brief in Support of Humira Plaintiffs
The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.
Promising Results in CD, UC for Celltrion Infliximab Biosimilar
Celltrion Healthcare reports on progress with higher predose levels of the infliximab biosimilar Remsima in patients with Crohn disease (CD) and ulcerative colitis (UC).
Report: Specialty Drug Assessment Highlights Biosimilar Progress
Sometimes the reference product exhibits pricing resistance against the competitive effect of biosimilars, according to a Pharmaceutical Strategies Group report.
Biosimilars Poll: What is Your Opinion on Clinical Efficacy Trials?
There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.
Study: Efficacy Trials Cost More, Take Longer for Biosimilars Than Originators
Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.
Celltrion Healthcare Advances Trials for Omalizumab Biosimilar
The product would target the lucrative, billion-dollar worldwide market for Xolair.
International Presenters Share Tips on Beefing Up Biosimilar Use
As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.
The Top 5 Biosimilar Articles for the Week of October 5
Here are the top 5 biosimilar articles for the week of October 5, 2020.
UK Regulators Seek Response on Waiving Comparative Efficacy Testing
Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.
FDA Reshuffles Priorities to Meet COVID-19 Trial Demand
The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.
IQVIA: Biosimilars Could Save $100 Billion Over Next 5 Years
A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.
EMA Begins Review of Samsung Bioepis' Ranibizumab
The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.
Medicure and Reliance Team Up for Cardiovascular Biosimilar
The agreement enables Reliance Life Sciences to springboard into the US market using Medicure's commercial reach.
Review: FDA Should Reconsider Interchangeability Requirements
Researchers contend the "totality of evidence" for biosimilar approval may be sufficient to demonstrate interchangeability.
ASCO Survey Measures COVID-19 Effect on Cancer Treatment
During the coronavirus disease 2019 (COVID-19) pandemic, patients are more likely to have delayed cancer screenings rather than their doctors and clinics.
Accord Launches 2 Biosimilars in the UK, Expands Partnership With Henlius
Accord brought 2 biosimilars referencing blockbuster oncology products to the United Kingdom and amended its agreement with Shanghai Henlius Biotech.
The Top 5 Biosimilar Articles for the Week of September 28
Here are the top 5 biosimilar articles for the week of September 28, 2020.