News

A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.

European investigators have derived a set of core principals for developing higher utilization of biosimilars.

Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.

Here are the top 5 biosimilar articles for the week of October 19, 2020.

Overcoming biosimilar uptake barriers will take collaboration and policy change by hospitals, infusion clinics, and health plans, presenters said at the Academy of Managed Care Pharmacy Nexus 2020 Virtual conference.

Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.

Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.

An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.

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.

Before its acquisition this year, Dean Foods attempted a specialty drug carve-out to save with biosimilars and generics.

Roche attributes a $3.83 billion reduction in sales to biosimilar competition.

Here are the top 5 biosimilar articles for the week of October 12, 2020.

DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.

Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.

Alexion and Celltrion separately announce advances in their drug development and marketing efforts.

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.

Celltrion Healthcare reports on progress with higher predose levels of the infliximab biosimilar Remsima in patients with Crohn disease (CD) and ulcerative colitis (UC).

Sometimes the reference product exhibits pricing resistance against the competitive effect of biosimilars, according to a Pharmaceutical Strategies Group report.

There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.

The product would target the lucrative, billion-dollar worldwide market for Xolair.

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.

Here are the top 5 biosimilar articles for the week of October 5, 2020.

Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.

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.

A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.