Biosimilars

The list of potential adalimumab biosimilars has now lengthened to 10, according to a Cardinal Health summary of these products and their distinguishing features.

Generics and biosimilars are reimbursed differently, causing providers to prefer lower-cost generics and higher-priced biologics, authors of a study and opinion piece contend.

As the cost of oncology drugs increases, there has been a growing pressure to manage oncology drug spend, which some payers have done by establishing preferred therapies, including biosimilars.

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development guidelines.

Sandoz, Lupin, and Biocon Biologics representatives at the Association for Accessible Medicines (AAM) GRx+Biosims conference said that drug price rebates hinder biosimilar competition.

For trastuzumab and bevacizumab, biosimilars now represent a high share of administrations, but payer policies still hinder uptake of these products, the Community Oncology Alliance (COA) reports.

There is now a mad scramble to gain interchangeable status for biosimilars, but the meaning and significance of this appellation haven't yet been worked out for health care consumers or the manufacturing community.

An overview of activities at the FDA to promote the use of biosimilars was presented by Jacqueline Corrigan-Curay, JD, MD, principal deputy center director for the Center for Drug Evaluation and Research (CDER) at the FDA.

Pharmacy experts from IPD Analytics explained the potential for authorized biologics, which would compete, potentially on the same price footing, with biosimilars.

There are a number of trastuzumab biosimilars available, but so far there have not been any patient characteristics that have played a role in which ones are prescribed, said Cate Lockhart, PhD, PharmD, MS, program, director, Biologics and Biosimilars Collective Intelligence Consortium.

Education is needed for both patients and pharmacists to ensure appropriate understanding, investigators reported at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.

Adalimumab biosimilar AVT02 exhibited comparative efficacy, safety, tolerability, and immunogenicity to the reference drug Humira in patients with moderate-to-severe chronic plaque psoriasis.

Kirollos Hanna, PharmD, manager of Oncology Pharmacy at the University of Minnesota Medical Center, explains the process behind how his practice chooses which biosimilars to stock and provide for patients.

Investigators concluded that reference or biosimilar pegfilgrastim could be safely administered to patients with lymphoma on the same day they receive chemotherapy, which could reduce scheduling burden and risk of COVID-19 exposure.

Kirollos Hanna, PharmD, manager of Oncology Pharmacy at the University of Minnesota Medical Center, discusses the uptake of oncology biosimilars at his practice.

Brazilian oncologists showed a solid knowledge base about biosimilars and their safety; however, concerns over extrapolation and interchangeability requirements remained, suggesting that more education on these subjects is needed.

Regulatory agencies have already begun calling companies out for misdirecting the public about the safety and efficacy of reference products in comparison to biosimilars, and it's important to continue to do so, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Bevacizumab biosimilar LY01008 demonstrated comparative safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product Avastin when combined with paclitaxel and carboplatin in patients with non–small cell lung cancer (NSCLC).

The emergence of new COVID-19 variants and the lower-than-anticipated vaccination rates could lead to a greater use of pegfilgratim biosimilars in cancer settings, explained Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Byooviz becomes the first FDA-approved ophthalmology biosimilar and the first FDA-approved biosimilar referencing Lucentis (ranibizumab), according to a statement from developers Samsung Bioepis and Biogen.

Cost and lack of insurance are big drivers of why a physician may choose to prescribe a pegfilgrastim biosimilar over the convenient on-body device for the originator, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Samsung Bioepis found during a 5-year follow-up study that Ontruzant, the company’s trastuzumab biosimilar, had comparable cardiac safety and long-term efficacy with the reference product Herceptin.

Reducing the risks of secondary neutropenia, exposure to COVID-19, mortality, and financial toxicity were all major reasons the use of pegfilgrastim biosimilar gained traction during the pandemic, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care.

Bio-Thera Solutions and Sandoz have partnered for to allow for the commercialization of BAT1706, a bevacizumab biosimilar referencing Avastin, for the treatment of several forms of cancer.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, discussed physician anticipation for the first biosimilars for programmed death (PD)-1 inhibitors.

Switching from Herceptin (reference trastuzumab) to trastuzumab biosimilars could significantly reduce direct medication costs attributed to breast cancer management in Saudi Arabia, researchers concluded.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, talks about the anticipation for more biosimilars to enter the oncology market and the current level of interest in the pipeline.

In comparison with reference rituximab (Rituxan), the use of rituximab biosimilars in combination therapy produced similar 3-year overall survival among patients with large-B-cell lymphoma (DLBCL), investigators concluded.

Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, this study found that site of care can change this calculus, reducing savings.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, discusses the potential for biosimilar utilization to grow and the reasons why his practice favors them over reference products.