Jackie Syrop

August 10, 2017

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.

August 08, 2017

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.

August 08, 2017

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.

August 04, 2017

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.

August 03, 2017

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.

August 02, 2017

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.

August 01, 2017

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.

July 29, 2017

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.

July 28, 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.

July 27, 2017

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.