Jackie Syrop

Jeff Bezos, Amazon’s founder and CEO, said that reducing healthcare’s burden on the economy while improving outcomes for employees and their families would be worth the effort, and the 3 companies had the talented experts with fresh approaches and a long-term orientation that will be key to success.

A recent study, set in the Netherlands, sought to assess patients’ attitudes about redistributing unused, subcutaneously administered biologic drugs, which could allow potential cost savings for the health system. However, the study unexpectedly found alarming storage inconsistencies and patient nonadherence to storage guidelines for these drugs.

Healthcare spending for the Medicaid expansion population increased steadily over time for beneficiaries who remained enrolled in Medicaid, according to a new analysis from Avalere Health. The analysis also found that spending for prescription drugs increased over the study period, with pharmacy costs (excluding prescription drug claims for hepatitis C treatments) almost doubling over the 2.5-year time period during which the cohort was tracked

Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.

SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.

Targeting sustained and stringently defined clinical remission in patients with moderately active rheumatoid arthritis (RA) receiving full-dose combination therapy with etanercept plus methotrexate before considering dose or regimen changes may help improve the likelihood that patients will remain in clinical remission 1 year after the changes are made.

Four hospital groups, representing approximately 450 US hospitals, are planning to create their own nonprofit generic drug company in a bold move designed to address generic drug shortages and high prices affecting their hospitals.

Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.

In an expert review, the authors provide transparency about biosimilar production, approvals, risk, and benefits to help improve confidence that the same safety and efficacy can be expected from biologics and their biosimilars.

Researchers based in the Republic of Korea have published data suggesting that they were able to produce a promising biosimilar obinutuzumab candidate from the plant Nicotiana benthamiana L. that is equivalent to obinutuzumab produced in glyco-engineered Chinese hamster ovary cells.

Patients with rheumatoid arthritis (RA) who require a change in therapy from anti–tumor necrosis factor inhibitor (anti-TNF) treatments to biologics with a different mechanism of action (MOA) had higher treatment persistence and lower healthcare costs than patients who cycled anti-TNF drugs, resulting in lower healthcare costs per persistent patient among the MOA switchers, a recent study finds.

FDA Commissioner Scott Gottlieb, MD, has said that he is open to rethinking the aspects of a 35-year-old law that create incentives for drug companies to develop orphan drugs for rare diseases affecting fewer than 200,000 people, because the market has changed since the law was passed.

Rituximab (Rituxan) is more effective and has lower rates of discontinuation than other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis, according to a Swedish study published online in the January 8, 2018, issue of JAMA Neurology.

Intravitreal injection of bevacizumab (Avastin) has revolutionized the treatment of diabetic eye disease, and has emerged as an important treatment modality, either as primary or adjuvant therapy for diabetic macular edema and proliferative diabetic retinopathy.

Writing in a Perspectives article, Michele K. Dougherty, PhD, and colleagues at the FDA predict the success of the agency’s biosimilars program and anticipate that as biosimilar development programs continue to mature, there will be an influx of biosimilar approval applications filed at the agency, and that the FDA and the biopharmaceutical industry will continue to build on the lessons learned from early biosimilar development programs.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

Patients with renal anemia undergoing hemodialysis who were treated for up to 24 months with the intravenous biosimilar epoetin alfa HX575 (Binocrit) showed hemoglobin outcomes equivalent to reference epoetin alfa.

Many drugmakers rang in the new year with increases in list prices of dozens of drugs that will take effect in 2018.

A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).

As the treatment paradigm in inflammatory bowel disease (IBD) has shifted from controlling symptoms to fully controlling disease in order to prevent organ damage and disability, some have argued that disability is a better, more objective measure than quality of life in clinical trials and population studies of IBD.

Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.

Antidrug antibodies (ADAs) are commonly found in healthy subjects after a single intravenous dose of infliximab and result in faster clearance of infliximab, shorter elimination time, and lower serum infliximab levels, according to a study published in the September 2017 issue of Drugs in R&D by Eli D. Ehrenpreis, MD.

Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.

A Polish study of axial spondyloarthritis patients who discontinued treatment with anti–tumor necrosis factor (anti-TNF) therapy because of low disease activity found that more than half eventually needed to restart anti-TNF therapy.

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

The tax reform bill proposed by Republicans and passed by the House this week contains benefits for many in the pharmaceutical industry. The reduction in the corporate tax rate from 35% to 21% will benefit all cash-flow-positive businesses, and the new, lower 15.5% rate for repatriating cash held overseas is likely to result in large companies becoming flush with cash, allowing them to buy back stock, increase shareholder returns, and fuel a wave of merger and acquisition (M&A) activity.

Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.

Improvements in the efficiency of certain research and development (R&D) processes and the wider adoption of new technologies are cause for optimisim.