Biosimilars

The 1-year gap after the end of the Oncology Care Model (OCM) means some practices have to make hard decisions regarding cost of care or the financial health of the practice, explained Lalan Wilfong, MD, vice president of Payer Relations & Practice Transformation at The US Oncology Network.

Having a biosimilar on formulary makes it more likely the biosimilar will be adopted. Length of time a biosimilar is on market can impact how likely it is to be added to formulary.

The FDA approved the first high-concentration adalimumab biosimilar. A low-concentration version of the biosimilar, Hadlima, was already approved. Both versions will launch in July 2023.

A number of psychologic interventions were assessed to see if they could have an effect on patient confidence in biosimilars to treat psoriasis.

Drs Oskouei and Alboustani discuss implications of multiple biosimilars for adalimumab and how indications are extrapolated for a biosimilar.

Drs Atheer Kaddis and Mariam Alboustani delve into biosimilar conversion programs, including switching policies for interchangeability.

The single-center study evaluated patients across multiple cancers to understand the utilization, safety, and financial outcomes of bevacizumab-awwb vs reference bevavizumab.

Dr Sonia T. Oskouei focuses on automatic substitution in both the pharmacy setting and in patients’ health plans.

Mariam Alboustani, PharmD, discusses the one published example of a switching study and the implications of interchangeability for pharmacists, as well as payers.

Although there is a paucity of data of switching among biosimilars of the same reference product, the few studies published support the safety and effectiveness of transitioning patients from one biosimilar to another.

Drs Kaddis and Oskouei define interchangeable biosimilars, their FDA requirements, and switching studies.

Atheer Kaddis, PharmD, and Sonia T. Oskouei, PharmD, BCMAS, DPLA, provide an overview of biosimilars and the preparation for future launches on the horizon.

The budget allocates half of the money for the development of low-cost interchangeable insulin biosimilars and the other half for building an insulin manufacturing facility in the state.

During its annual conference in Spain, Medicines for Europe shared recommendations for greater use of off-patent medications, such as biosimilars and generics, as a way ensure medicines remain available to patients in light of global events and supply chain issues.

Until recently, ophthalmologists in the United States have had no experience with biosimilars, despite the availability of biosimilars for bevacizumab, which is commonly used off label for ophthalmic conditions.

The study of postmenopausal women in Iran found the efficacy of the biosimilar was noninferior to the reference product and the safety was comparable after 18 months.

A survey of patients with breast cancer and oncologists found that when switching to a trastuzumab biosimilar from the reference product (Herceptin), many patients were not given adequate information on what biosimilars are and their benefits.

The oncology space has seen successful adoption of biosimilars thanks to processes and formulary decisions driving conversion rates.

Abstracts presented at the 2022 American Society of Clinical Oncology Annual Meeting show bevacizumab-awwb to be safe and effective for patients with metastatic colorectal cancer (mCRC) with high overall survival rates.

Advanced practitioners (APs) have a role to play in strategies for integrating biosimilars into clinical practice.

Among a real-world cohort of patients, switching between infliximab biosimilars was effective and well tolerated, although retention was higher among those who had initially started on the originator product.

Abstracts presented at the American Society of Clinical Oncology Annual Meeting evaluated biosimilar use in practices participating in the Oncology Care Model (OCM) and estimated the savings as a result of substituting these agents for more expensive reference products.

As part of the Biosimilars Initiative, British Columbia, Canada, implemented a mandatory switch to biosimilar insulin glargine for patients covered by the province’s drug plan.

Using biosimilar rituximab to replace the reference in a common combination regimen to treat diffuse large B-cell lymphoma (DLBCL) results in similar outcomes.

Real-world studies evaluating the safety and efficacy of switching to adalimumab biosimilars from the originator product confirmed the safety and efficacy of the biosimilars ABP 501 and SB5.

The FDA approval for Fylnetra represents the fifth approval for a biosimilar referencing Neulasta (pegfilgrastim) in the United States.

Research presented at EULAR 2022 demonstrated the pharmacokinetic equivalence of a low-concentration version of the adalimumab biosimilar SB5 and a high-concentration version.

Surveys of patients and oncologists found discrepancies between patient experiences and oncologist perceptions of those experiences during a nonmedical switch to trastuzumab biosimilars.

Alignment of incentives in the United States do not always support the use of biosimilars or other lower-cost alternatives, said Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health.

As biosimilar competition heats up in the United States, payers have more tools at their disposal to manage these agents.