Jackie Syrop

According to a new study, potential savings realized from transitioning to treatment with biosimilar filgrastim-sndz from reference filgrastim are not only significant, but these savings can also be applied to expand access to novel immunotherapies or supportive care.

The epoetin alfa biosimilar HX575 (Binocrit, a product of Sandoz) was approved in the European Union in 2007 for the treatment of chemotherapy-induced anemia (CIA) and anemia associated with chronic renal failure.

Three posters presented on September 10, 2017, at the European Society for Medical Oncology (ESMO) 2017 meeting in Madrid, Spain, covered research on 2 proposed pegfilgrastim biosimilars and evaluated the use of filgrastim in oncology practice.

Poster presentations at this week’s European Society for Medical Oncology (ESMO) conference include the results of 5 studies on biosimilar trastuzumab candidates.

Although switching patients with rheumatoid arthritis to a second biologic disease-modifying anti-rheumatic drug when their disease has failed to respond to the first agent is generally advocated, no consensus exists on whether the second agent should have the same or a different mechanism of action.

Biologic agents represent the highest single cost associated with rheumatoid arthritis (RA) infusion care, a new analysis finds, with personnel, supplies, and overhead costs contributing substantially to overall costs.

Several small studies have suggested that ultra–low-dose treatment with rituximab leads to good treatment responses in patients with rheumatoid arthritis compared with standard low-dose schedules of rituximab.

Several biosimilar etanercept products are now approved in the United States and in Europe, and several more “intended copy” versions are approved in poorly regulated countries. Availability of an international reference standard would allow qualification of assays for determining biological activity of intended copies or biosimilars.

Insulin degludec (Tresiba) is a cost-effective alternative to insulin glargine U100 (Lantus) for patients with diabetes, and it is also likely to be more cost-effective than 2 newly marketed basal insulin analogues, including a biosimilar.

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in many patients who take these biologics, and leads to higher costs.

Treatment strategies involving anti-tumor necrosis factor dose tapering or withdrawal among rheumatoid arthritis patients who are achieving disease control are gaining popularity. Such strategies seek to optimize benefits versus risks with respect to both patient preferences and the high costs of biologic treatments.

Cost-effectiveness evidence has come to play a prominent role in decisions regarding the approval of expensive biologic treatments, such as those for psoriatic arthritis (PA). However, cost-effectiveness evidence for PA treatments has been difficult to develop because of the lack of a robust evidence base.

Providing prophylactic treatment with granulocyte-colony stimulating factor to patients receiving chemotherapy may yield better chemotherapy-induced neutropenia, febrile neutropenia, and related hospitalization outcomes if patients receive prophylaxis at levels above guideline recommendations, according to a recent study.

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.

A phase 1 trial of ABP 980, Amgen’s proposed biosimilar of reference trastuzumab (Herceptin), demonstrated ABP 980’s pharmacokinetic similarity to both US-approved reference trastuzumab and European Union-approved reference trastuzumab. Amgen and Allergan have submitted applications for approval of ABP 980 with both the FDA and the European Medicines Agency.

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.

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.

A recent international, randomized, double-blind study comparing the proposed biosimilar GP2013with both the reference rituximab approved in the European Union and in the United States found that GP2013 demonstrated 3-way pharmacokinetic and pharmacodynamic equivalence with both products in patients with rheumatoid arthritis.

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.

The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.

A recently published study shows that Amgen’s ABP 501 (Amjevita), referenced on Humira, shows that the product has similar efficacy, safety, and immunogenicity to its reference in patients with moderate to severe rheumatoid arthritis.

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.

An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.

The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.

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 analysis of available data strongly confirms the equivalence of reference infliximab and CT-P13, and data are reassuring about the switching approach from the reference drug to biosimilar.