Biosimilars

In 2022, the articles published in the peer-reviewed The American Journal of Managed Care® (AJMC®) explored care management interventions, savings from biosimilars, and much more.

The top biosimilars content of 2022 reviewed perceptions around switching to a trastuzumab biosimilar, drug costs, and the successful implementation of biosimilars in practice.

Abstracts presented at the annual meeting of the American College of Rheumatology (ACR) show 2 tocilizumab biosimilars were comparable to the reference product.

Biosimilar use in clinical practice is determined by oncologists’ perceptions of and willingness to prescribe them. The authors investigated US oncologists’ perceptions and use of biosimilars.

Due to anticompetitive practices, the United States lags Germany and Switzerland in the number of biosimilars on the market, while also having substantially higher prices for both biosimilars and reference products.

Abstracts show that institutions can make internal changes to drive the use of biosimilars and that successful biosimilar-to-biosimilar switching is based on patient-related factors.

A bill introduced by Senator Mike Lee, R-Utah, would prohibit the FDA requiring switching studies for biosimilars to gain interchangeability status.

Switching from the originator products to biosimilars or between biosimilars is safe and effective, according to a review of real-world studies.

Findings suggest that Basaglar was not less expensive for patients than Lantus. Empirical evaluation of biosimilar costs prior to automatic substitution is necessary.

Ahead of the big wave of adalimumab biosimilars launching in the US market in 2023, rheumatologists report growing confidence in using biosimilars but remain concerned about their efficacy and economic benefit.

Coverage from the Atlanta meeting of the Institute for Value-Based Medicine, chaired by Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services, Emory Healthcare and Emory Winship Cancer Institute.

The bill was introduced by 2 Republicans and 2 Democrats and would direct HHS to undertake a study to understand how substitution of interchangeable biologic products may be impeded.

One of the first parts of the landmark Inflation Reduction Act took effect Monday; it boosts the add-on payment for qualifying biosimilars whose average sales price is not more than the price of its reference product from 6% of the reference product’s ASP to 8% for 5 years.

Sonia T. Oskouei, PharmD, BCMAS, DPLA, navigates the impact of the VOLTAIRE-X study, the only published switching study for adalimumab, on biosimilar uptake.

With 6 pegfilgrastim biosimilars approved, and multiple administration options, a patient-centric model of pegfilgrastim administration should be possible for patients with cancer who require prophylaxis of febrile neutropenia.

The authors evaluate the effect and safety of biosimilar trastuzumab MYL-1401O in human epidermal growth factor receptor 2 (HER2)–positive early-stage (neoadjuvant and adjuvant therapy) and metastatic (palliative therapy) breast cancer using real-world data.

While commercial payers have been engaged with the shift to biosimilars, they all have their own preferred biosimilar, which makes it challenging for practices, explained Lalan Wilfong, MD, vice president of payer relations & practice transformation at The US Oncology Network.

In 2021, the specialty drug trend rebounded from the pandemic, and it is expected to stay strong with more specialty drugs coming. Increased availability of biosimilars could shift this trend.

While initially there was a need for education around biosimilars, now there is a need to keep an eye on the evolving biosimilar marketplace and update the formulary of biosimilar medicines, said Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.

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.