Biosimilars

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.

A biosimilar adoption integration process that included full staff education, physician consent, and systematic auto- conversion proved to be feasible and scalable, and resulted in rapid conversion from reference product to FDA-approved biosimilar.

A retrospective, cross-sectional review reported significant uptake of biosimilar filgrastim products in Medicare Part D from 2015 to 2019 being associated with a small decrease in aggregate spending, essentially unchanged per-unit spending, and increased spending per beneficiary on filgrastim products, all attributed to the inability of Medicare Part D to directly negotiate prices with manufacturers.

Prospective evaluation of real-world biosimilar-related cost-savings and adoption indicates that biosimilar utilization in community oncology practices can result in significant cost-savings.

The preliminary findings of a retrospective study that analyzed healthcare claims from the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network between 2016 and 2020 indicate that utilization of biosimilar trastuzumab-anns increased over time, whereas the use of trastuzumab reference decreased.

Simulation models demonstrate substantial cost-savings realized by conversion to biosimilar pegfilgrastim-cbqv for chemotherapy-induced (febrile) neutropenia prophylaxis in patients with metastatic pancreatic cancer, and that these cost-savings could be reallocated to provide access to antineoplastic treatment on a budget-neutral basis.

This past year, the COVID-19 pandemic continued to impact the practice of medicine and the dissemination of treatment advances presented in scientific forums.

The results of a phase 3, randomized, double-blind study established the equivalence of bevacizumab reference to its biosimilar BCD-021 in terms of clinical efficacy, safety, pharmacokinetics, and immunogenicity in patients with NSCLC.

The 5-year follow-up results of a comparative phase 3 study further support the similarity of SB3 and trastuzumab reference with respect to cardiac safety profile and long-term efficacy.