After Public Drug Coverage for Infliximab, Adalimumab, Surgeries and ED Visits for CD Fell
October 29th 2019Between 2003 to 2014, patients in Ontario, Canada, received public drug benefits for infliximab or adalimumab at a combined rate of 2.2% in 2003, rising to 18.8% of eligible patients by 2014. During that period, the prevalence of Crohn‐related hospitalizations fell 32.4%.
Pfizer Announces Launch Dates for 2 More Anticancer Biosimilars: Ruxience and Trazimera
October 29th 2019Albert Bourla, DVM, PhD, Pfizer’s chief executive officer, announced during the company’s third quarter 2019 earnings call that Pfizer has set launch dates for its biosimilar rituximab, Ruxience (referencing Rituxan), and trastuzumab, Trazimera (referencing Herceptin).
ACG Case Studies Report on AEs, and Their Resolution, With Biosimilar Infliximab
October 29th 2019This week, clinicians gathered in San Antonio, Texas, for the American College of Gastroenterology (ACG)’s 2019 meeting, where a number of presentations focused on the treatment of inflammatory bowel disease. During the congress, 2 studies presented addressed adverse events (AEs) associated with—one of which was resolved by—the use of biosimilar infliximab, CT-P13 (Inflectra).
Could Results for Revance's Novel Botulinum Toxin Make a Biosimilar Botox Less Appealing?
October 29th 2019Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.
Bipartisan Patent Transparency Bill Introduced in House of Representatives
October 28th 2019A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.
In Psoriasis and Psoriatic Arthritis, CT-P13 Is Safe and Effective 1 Year After Mandatory Switch
October 28th 2019Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.
Formycon Starts Phase 1 Trial for Proposed Ustekinumab Biosimilar
October 28th 2019Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.
Innovator Drug Developers Gain New Indications in Bids to Mitigate Biosimilar Impact
October 26th 2019As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.
Biosimilars in the United States: Where We've Been and Where We're Headed
October 25th 2019Earlier this year, The Center for Biosimilars® staff sat down with our editorial advisory board member, Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center. In the interview, Abraham discussed how biosimilars have progressed in the United States over the past year, whether biosimilars are indeed delivering on their promised cost savings, and challenges that still lie ahead in the cancer space.
In Survey, Physicians Rank Their Own Confidence as the Primary Barrier to Biosimilar Adoption
October 25th 2019When it comes to considering using biosimilars, savings for patients are providers’ top concern, followed by savings to the healthcare system at large. Yet physicians also rate their own confidence levels in biosimilars as a main hurdle for widespread biosimilar adoption.
Canadian Gastroenterology Groups Issue Joint Position That Takes Aim at Nonmedical Switching
October 25th 2019The Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.
Pooled Analysis Underscores Safety of Biosimilar Infliximab, CT-P13, in Patients With IBD
October 24th 2019During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.
Cost May Drive Medicare Patients to Delay or Forego Treatment for Blood Cancer, Report Suggests
October 24th 2019A new research report from Milliman, commissioned by the Leukemia and Lymphoma Society (LLS), found that fewer than half of patients with blood cancer received treatment within 3 months of diagnosis, and LLS says that costs may be keeping patients from getting care.
Is a Window of Opportunity Closing for US Biosimilars?
October 24th 2019Writing in a viewpoint in JAMA, Walid F. Gellad, MD, MPH, and Chester B. Good, MD, MPH, both of the University of Pittsburgh, argue that the deep cost savings achieved in Europe for biosimilar adalimumab are unavailable to the United States because of settlements struck between AbbVie and the developers of all FDA-approved biosimilars.
House GOP Lays Out Healthcare Vision in Blueprint
October 23rd 2019Republicans in the House of Representatives this week laid out their alternative to the Affordable Care Act (ACA) in an effort to position themselves against various Democratic healthcare proposals. The document contains many ideas that have been debated previously when Republicans tried to repeal the ACA, and it draws on work from the Heritage Foundation and the Cato Institute.
WHO and IGBA Sign Agreement to Promote Biosimilars and Generics
October 23rd 2019The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.
At UEG 2019, Data Shed Light on Monitoring of Biosimilar Adalimumab, Imraldi, in IBD
October 22nd 2019Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.
Ahead of FDA Decision on ABP 710, Study Shows Biosimilar's PK Similarity to Reference Infliximab
October 22nd 2019In December 2018, biosimilar developer Amgen announced that it had submitted its proposed infliximab biosimilar, ABP 710, referencing Remicade, to the FDA for review. A regulatory decision is expected shortly, and last week, researchers published detailed results from the biosimilar’s phase 1 clinical study that evaluated the pharmacokinetic (PK) similarity of the biosimilar with its reference.
In IBD, Celltrion's Subcutaneous Infliximab Biosimilar Proves Noninferior to Intravenous Option
October 21st 2019During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).
Preparing for the 2020 Regulatory Transition of Insulin and Other Therapeutic Proteins
October 21st 2019Are you ready for the upcoming 2020 transition of insulins and other therapeutic proteins to US regulation as biologics and biosimilars? Find out what you need to know about the regulatory change with a new ebook from The Center for Biosimilars®.