Practice

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.

Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.

Pharmacy Benefit Manager CVS Health, which has over 90 million members, has released the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.

Recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and its long-acting pegylated form, pegfilgrastim, are widely used to reduce the risk of chemotherapy-induced neutropenia, but to date, no pegfilgrastim biosimilar has been approved in highly regulated markets such as Europe, Japan, and the United States.

Treatment guidelines for ovarian and cervical cancer recommend the use of the angiogenesis inhibitor bevacizumab (Avastin), but patient access to this medication and other angiogenesis inhibitors is limited.

While US healthcare providers are growing more willing to adopt lower-cost biosimilar drugs as way to address the rising costs of biologic treatment, biosimilar developers are facing yet another challenge: competing against reference products for a preferred place on formularies.

A recent Spanish study concludes that CT-P13, a biosimilar of reference infliximab that has been approved in Korea, the European Union, and the United States, is efficacious and well tolerated in patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC).

In 2014, Germany had the highest use of biosimilars in Europe, with around 50% volume uptake. Yet data found that German patients have shown some reluctance to accept biosimilars.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists yields 3 key takeaways concerning the future of the increasingly competitive ulcerative colitis market.

Price competition in the US insulin market is heating up; Novo Nordisk reported in its second-quarter earnings call that its 2018 US insulin prices could drop below 2017 levels.

The Canadian Agency for Drugs and Technologies in Health reviewed the clinical effectiveness, cost-effectiveness, and advice from guidelines concerning switching from innovator to biosimilar infliximab for the treatment of several autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.

A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.

Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.

The introduction of anti-tumor necrosis factor-alpha agents has improved treatment options for patients with inflammatory bowel disease. However, these agents can also lead to increased vulnerability to infections, development of autoimmune diseases, malignancies, and decreased immunogenicity of vaccinations.

Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.

A recent survey of 588 Canadian patients revealed that many patients had serious concerns about biosimilar substitution.

Data from a recent study show that biosimilar filgrastim is readily used in France for the prophylaxis of chemotherapy-induced neutropenia. The data also demonstrate that clinicians’ assessment of febrile neutropenia risk is driven by patient factors more than by the European Organisation for the Research and Treatment of Cancer’s risk category of the chemotherapy regimen.

A recent survey shows that some patients have greater concerns about automatic substitution of biosimilar products than they do about the high cost of biologic drugs.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer, but biosimilars are not without concerns.

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

On Thursday, the Oncology Business Review (OBR) hosted a panel discussion, “The Advent of Biosimilars in Oncology: Planning Proactively for Change.”

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 24, 2017.

The potential immunogenicity of biosimilar agents is an important consideration in the treatment decision-making process, and a new systematic review of immunogenicity associated with biological therapies in chronic inflammatory diseases explores the frequency of immunogenicity and its potential impact on efficacy and safety.

A new survey assessing awareness of and attitudes about biosimilars among medical specialists and pharmacists in Ireland found that majority of such experts say that they are familiar or very familiar with the term “biosimilar,” but many general practitioners (GPs) were either unable to define or had never heard the term.

An analysis of 53 switching studies reveals a variable level of good-quality evidence regarding switching from reference drugs to their biosimilars.

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.