Biosimilars

Biosimilars have had such an impact on driving down costs, that in some instances the reference product might be the lowest cost option, explained Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.

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.

With more and more biosimilars reaching market, there are considerations around whether to keep patients on their current biosimilar or switch them to another biosimilar as the market dictates, said Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.

In her final thoughts, Dr Oskouei discusses how patient care may be improved by increased access to biosimilars.

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 Oskouei explores the managed care landscape and opportunities for increasing biosimilar uptake to improve patient care.

When converting a patient to a biosimilar, having clear and consistent messaging will reduce confusion and prevent patients from having a lack of trust in the process, said Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.

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.

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.