The U.S. health insurance provider Cigna has provided a financial incentive to patients who switch to an infliximab biosimilar, through a one-time $500 debit card for health care services and products called the “Shared Savings Program.” Cigna has promoted this program as a way to promote biosimilar use and reduce…
In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition. The white paper studied the price and…
On February 18, 2021, the American Journal of Health-System Pharmacy published the results of a meta-analysis evaluating the use of infliximab in patients with rheumatoid arthritis (RA). The meta-analysis evaluated patient response rates to treatment with the infliximab reference product REMICADE compared to treatment with infliximab biosimilars. The study’s authors…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…
Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab). According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara. NeuLara…
Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture. Celltrion has said it plans to finish Phase…
Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…
According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease. CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a potential biosimilar to bevacizumab, met pre-defined primary endpoints in two clinical trials against branded bevacizumab. One trial was a phase III clinical trial that compared…