2021 Year in Review - Biosimilars

The results of a randomized, double-blind phase 3 study established the equivalence of bevacizumab reference to its biosimilar MIL60 in terms of clinical efficacy, safety, population pharmacokinetics, and immunogenicity in patients with nonsquamous NSCLC.

The results of a noninterventional, retrospective study showed that rituximab originator and the rituximab-abbs biosimilars yielded comparable efficacy and tolerability in the first-line treatment of patients with CLL and NHL, with rituximab-abbs use resulting in cost-savings.

Findings from modeling studies support adjuvant continuation of pertuzumab plus trastuzumab for patients achieving pathologic complete response among patients with high-risk, HER2-positive early breast cancer.

Real-world outcomes from a retrospective, single-center study suggested that pegfilgrastim or its biosimilar pegfilgrastim-cbqv does not increase febrile neutropenia or delayed engraftment risk in patients with lymphoma and CLL and may be safe to use after administration of chemotherapy.

The results of a retrospective, single-center analysis demonstrated that same-day pegfilgrastim or pegfilgrastim-cbqv was safe and effective in patients with diffuse large B-cell lymphoma who received a rituximab plus miniCHOP chemotherapy regimen, with no significant increase in febrile neutropenia or delayed engraftment.

Real-world evidence demonstrated that the characteristics of patients with metastatic colorectal cancer who received bevacizumab-awwb in the first year after product launch were similar regardless of prior bevacizumab use, and that beva­cizumab-awwb was used in new and continuing patients.

An observational study indicates that the Oncology Care Model led to reduced use of some high-cost supportive care medications, suggesting the potential for alternative payment models to drive value-based changes in cancer medication use.

The findings of a simulation modeling analysis demonstrate that conversion from pegfilgrastim with on-body injector to pegfilgrastim-jmdb provides significant cost-savings, which could be reallocated on a budget-neutral basis to provide expanded access to additional prophylaxis or to antineoplastic therapy in patients with diffuse large B-cell lymphoma.

A pharmacokinetic study demonstrated bioequivalence between SB12 and the eculizumab reference products, along with comparable pharmacodynamics, safety, and immunogenicity.

The preliminary results of a phase 2 study indicate that the combination of rituximab biosimilar plus pegylated interferon α-2b was well-tolerated and yielded responses in newly diagnosed advanced indolent B-cell NHL.