The American Journal of Managed Care, a sister site of The Center for Biosimilars, looked back at some of the most popular biosimilars content of 2022 to be published on AJMC.com.
Both 2020 and 2021 were slow years for biosimilar approvals in the United States, but there were 7 total approved as of mid-December 2022. As more biosimilars come to market in the United States, there is interest in understanding how to implement biosimilars in practice and the cost savings that can be realized from greater use of biosimilars.
Here are the top 5 most popular biosimilars articles from 2022.
5. Patient Experiences, Oncologist Perceptions Differ for Trastuzumab Biosimilar Switch
Switching from a reference product to a biosimilar commonly happens for nonmedical reasons. Biosimilars are less expensive than the reference biologic and insurers or health care systems may lead the decision for this nonmedical switching.
However, a set of surveys revealed that patients and oncologists need improved communication regarding switching to trastuzumab biosimilars, and 41% of patients reported receiving no prior notification ahead of the switch. None of the oncologists surveyed reported that the decision to switch to a biosimilar was initiated by them.
4. High-Concentration Version of Adalimumab Biosimilar Will Be Available in 2023
While the FDA had approved multiple adalimumab biosimilars prior, this represented the first high-concentration citrate-free formulation of an adalimumab biosimilar approved by the FDA. Both the low- and high-concentration versions of Samsung Bioepis’ adalimumab biosimilar, Hadlima, will launch July 2023.
The citrate-free, high-concentration version reduces site injection pain. Currently, the high-concentration version of the reference product has the most market share.
3. Biosimilars Available for 3 Drugs Costing More Through Hospitals, Physicians
A report from AHIP analyzed the cost of 10 drugs and found those administered in a hospital or physician’s office can cost up to twice as much as the same drugs dispensed in specialty pharmacies.
Three of the drugs evaluated have multiple biosimilars available: Herceptin with 5 biosimilars available; Remicade with 4 biosimilars approved and 3 on the market; and Rituxan with 3 biosimilars available.
2. FDA Approves Third Bevacizumab Biosimilar
In April 2022, the FDA approved Alymsys, a bevacizumab biosimilar from Amneal Pharmaceuticals and mAbxience. It was the third biosimilar referencing Avastin to be approved in the United States. Alymsys was also the second biosimilar from Amneal approved in 2022.
Amneal’s first biosimilar approved of 2022 was Releuko, a filgrastim biosimilar. The company also had a pegfilgrastim biosimilar, Fylnetra, that was approved in June 2022.
1. Dr Timothy Murphy Discusses Successfully Implementing Biosimilars Into Community Cancer Practice
Timothy Murphy, MD, medical oncologist/hematologist with Rocky Mountain Cancer Centers (RMCC) discussed how his practice is handling the growing number of biosimilars. Educating providers and the pharmacy team was crucial for the success RMCC had had.
“We had to convince our providers that switching the drugs that they have written for with a biosimilar was an OK thing to do, that these medications are just as efficacious as the name brand drugs that they may have actually written for it,” he said.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.