Phase 3 Data for Zirabev Show Similarity of the Biosimilar and Reference Bevacizumab
July 25th 2019Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.
Conservative Thinkers Share Their Views for Biosimilars in a Post-ACA, BPCIA Landscape
July 24th 2019Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.
Court Calls Genentech's Actions In Trastuzumab Case "Contrary to the Spirit" of the BPCIA
July 24th 2019Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.
Biosimilar Provisions Feature Heavily in Senate Finance Bill
July 24th 2019The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.
Bipartisan Senate Bill Takes Aim at Insulin Prices
July 23rd 2019A bipartisan bill introduced in the Senate Monday calls for cutting insulin prices up to 75% via a measure aimed at insurers and pharmacy benefit managers (PBMs). The bill, introduced by Senator Jeanne Shaheen, D-New Hampshire, would prohibit PBMs and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels.
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
July 23rd 2019The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
Canadian Payer Applauds British Columbia for Switching Patients to Biosimilars
July 23rd 2019This month, the president and chief executive officer of Green Shield Canada, the fourth-largest private payer in Canada, hailed British Columbia’s strategy as “forward-thinking” and “essential to maximizing opportunities in healthcare.”
Time for Regulators to Acknowledge That Biosimilars Are Interchangeable, Paper Argues
July 23rd 2019"We argue that the default should be that biosimilars are interchangeable, unless there is compelling evidence otherwise," write Hans C. Ebers, PhD, of Biogen, and Hubb Schellekens, MD, PhD, of Utrecht University.
Little-Known Provision of Senate Healthcare Bill Has Some Biosimilar Stakeholders Worried
July 19th 2019When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.
Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States
July 19th 2019The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.
Adalimumab, Insulin Glargine, Etanercept Top 2018 Drug Spending List
July 18th 2019The top 3 drugs in 2018 in the United States by spending were adalimumab, insulin glargine, and etanercept, according to a study in The American Journal of Health-System Pharmacy, which also predicted that drug spending will grow 4% to 6% this year.
Recent Reports Explore Drug Survival, Cost Savings in Switches to Biosimilar Etanercept
July 18th 2019Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.
Multicenter European Study to Look at Real-World Experience of Patients Switched to Imraldi
July 18th 2019A hospital for rheumatological diseases in the United Kingdom is participating in an international study that is examining real-world evidence about patient experiences after they switch from reference adalimumab (Humira) to a biosimilar, Imraldi.
Using Value-Based RA Pathway Leads to a Shift to Biosimilars for AHG
July 17th 2019A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.
CBO Says Lower Health Care Costs Act Could Save $7.6 Billion by 2029
July 17th 2019According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.
Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name Drugs
July 17th 2019Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.
Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39
July 16th 2019Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
No Difference Seen in Cardiac Effects Between Ustekinumab, Anti-TNF Drugs for Psoriasis
July 15th 2019A recent study found no difference in the risk of developing atrial fibrillation (AF) or major adverse cardiovascular events (MACE) associated with ustekinumab versus anti–tumor necrosis factor (anti-TNF) therapy in patients with psoriasis or psoriatic arthritis.
In Eastern Europe, CT-P13 Provides Effective, Cost-Saving Alternative to Reference Infliximab in IBD
July 15th 2019Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.
In a Single-Center Study, Patients With AS Remained in Remission After a Switch to CT-P13
July 14th 2019As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.