Deana Ferreri, PhD

A financial evaluation study proposed a framework for choosing which biosimilar candidates companies should develop, a process that requires a detailed and careful analysis to ensure that the candidate will be successful in global biopharmaceutical markets.

An analysis of retrospective data demonstrated comparable safety and efficacy profiles between CT-P6, a trastuzumab biosimilar, and Herceptin (reference trastuzumab) combined with chemotherapy and pertuzumab.

A study assessing the impact of mandatory switching policies in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.

Authors of a new study demonstrated that multiple switches between infliximab biosimilars CT-P13 and SB2 and the reference product (Remicade) were safe and effective in patients with inflammatory bowel disease (IBD).

A sub-study assessing the affects of using a prefilled pen vs a prefilled syringe found that the pen was easy for patients to use and was favored by over 90% of patients.

A real-world analysis found similar safety and efficacy profiles between a biosimilar ranibizumab (Razumab) and the reference product (Lucentis, Accentrix) in Indian patients with diabetic macular edema.

An article reviewed the totality of evidence leading to the approval of Amgen’s infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade).

A patient with ankylosing spondylitis (AS) and ulcerative colitis (UC) was diagnosed with polychondritis after taking an infliximab biosimilar, suggesting that patients with similar circumstances should be carefully monitored.

Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients with breast cancer, investigators concluded.

The authors noted that “all biologic therapeutics can be immunogenic or elicit an immune response,” and that an assessment of immunogenicity is part of the totality of evidence required for regulatory approval of biosimilars.

Two new studies have investigated the adalimumab biosimilar SB5 (Imraldi; Samsung Bioepis) in inflammatory bowel disease (IBD; Crohn’s disease and ulcerative colitis) and non-anterior uveitis associated with Behcet's syndrome (BS).

Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.

Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.

A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.

Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.

In a review, Sandoz researchers discuss lingering barriers that prevent insulin prices from falling to more affordable levels.

A study of trastuzumab biosimilars and the reference product (Herceptin) under control and stress conditions elucidated the value of machine learning.

Authors of a review discuss barriers to insulin access and potential solutions as the 100-year anniversary of the drug's first use for diabetes gets closer.

Investigators in Spain said they found no significant differences in outcomes for patients who switched from adalimumab originator to 1 of multiple adalimumab biosimilars.

According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.

A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.

A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.

A retrospective study of rituximab biosimilars Truxima and Riximyo demonstrated comparable response and survival for patients with diffuse large B-cell lymphoma (DLBCL).

The average net price of all insulin glargine products decreased between 2015 and 2020 following the steady price increase seen for Lantus from 2010 to 2014.

Real-world study in Italy finds most patients with inflammatory bowel disease (IBD) maintain clinical and biochemical response after switching from infliximab reference product to SB2.

Authors of an opinion piece suggest that a "reliance" approach to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.

Investigators determine that converting at least 2 patients with metastatic breast cancer to a trastuzumab biosimilar could generate savings enough to treat a third patient.

Wider use of granulocyte colony-stimulating factor (G-CSF) biosimilars is recommended for patients at risk of febrile neutropenia (FN).

Investigators in British Columbia surveyed patients for their impressions of biosimilars before and after mandatory switching.

A Canada study of the filgrastim biosimilar Grastofil demonstrated equivalence to Neupogen in candidates for autologous stem cell transplantation (ASCT), an extrapolated use.