Biosimilars

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

Kathy Oubre, MS, closes this Insights program by evaluating her organization’s biosimilars program and formularies, including third party preference on the use of specific biosimilars and whether biosimilars can be used outside of their indications.

Two experts explain if they had to create any incentives for health care providers to prescribe biosimilars, whether they encountered challenges with their electronic health records, and if their biosimilar programs impacted their clinical pathway/care plans.

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.

Ryan Haumschild, PharmD, MS, MBA, and Kathy Oubre, MS, discuss tracking their use of biosimilar by their providers and outcome measures they utilize to monitor biosimilars.

Ryan Haumschild, PharmD, MS, MBA, and Kathy Oubre, MS, recall what protocols and laws their organizations needed to abide by when transitioning to their biosimilars programs.

Two experts examine how the biosimilar programs at their organization were created and the initial goals they had in mind.

Ryan Haumschild, PharmD, MS, MBA, and Kathy Oubre, MS, discuss the increased use of biosimilars, including successes and challenges and the process of transitioning to biosimilars at their organizations.

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.

Ryan Haumschild, PharmD, MS, MBA, discusses optimizing the transition to biosimilars, covering from what patients to look for as candidates to the process of switching a patient from a brand to a biosimilar to the importance of patient education.

Ryan Haumschild, PharmD, MS, MBA, continues focusing on transition optimization, explaining how to efficiently create your inventory, how his use of biosimilars will change in the future, and offering advice to those looking to transition to biosimilars.

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.