Deana Ferreri, PhD

European investigators have derived a set of core principals for developing higher utilization of biosimilars.

Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.

Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia

Germany could eke out more gains from biosimilars on top of its already impressive savings, investigators write.

Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.

The random jumble of letters that the FDA attaches to new biologics and biosimilars plays a big role in patient acceptance of these drugs, investigators report.

Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.

Two decades of using anti–tumor necrosis factor (TNF) drugs in inflammatory bowel disease (IBD) have answered some questions and left others unanswered.

Celltrion finds fault with a critique of equivalence margins used to approve its infliximab biosimilar.

A real-world study on inflammatory bowel disease employing originator and biosimilar biologics suggests anti–tumor necrosis factor (TNF) therapy may be more effective for Crohn disease than for ulcerative colitis.

Investigators speculate on why infliximab biosimilars don’t have a larger market share by now.

Wide variation in treatment patterns for Crohn disease is attributable to failures to translate evidence uniformly and cost barriers. Authors of a new report have formulated algorithms to help reduce heterogeneity in treatment of patients.

Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.

Rituximab was originally approved in the United States in 1997 for treatment of non-Hodgkin lymphoma and has multiple additional approvals for orphan and nonorphan indications. But a recent study found off-label uses now account for more than half of patients receiving rituximab.

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

The currently available anti–vascular endothelial growth factor (anti-VEGF) therapies for wet age-related macular degeneration (AMD) are costly, but biosimilars in clinical development may ease this problem.

A joint position statement on biosimilars for the treatment of inflammatory bowel disease (IBD) sparked backlash and criticism over the recommendation against nonmedical switching from reference infliximab to a biosimilar.

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Fresenius Kabi’s pegfilgrastim biosimilar candidate has demonstrated a similar safety and immunogenicity profile to the reference product (Neulasta).

Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence for biosimilars.

Although the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.

European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.

Patients in an Australian clinic were generally open to using biosimilars but knew little about them, according to a recent study.

In inflammatory bowel diseases (IBD), biosimilars have been available for roughly 5 years, but more evidence may be necessary to persuade medical community to increase usage, according to a study.

So many factors have the potential to affect the quality and performance of biosimilars that clinicians must be aware of the need for constant pharmacovigilance.

A gentle, persuasive effort to get patients and physicians to adopt biosimilars is likely to work better than a heavy-handed approach, say Canadian investigators, who recommend more study of how mindsets and prescribing practices are changed.

A review article contends that providers need to know more about the approval process for biosimilars and what data points are examined.

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

Because of the high cost of biologics, the authors recognized a need to provide access to evidence-based information on biosimilars for healthcare providers working with patients with inflammatory bowel disease.