Conferences throughout 2022 shared new information on white bagging, the safety of biosimilar substitution, the use of a biobetter, and discussion around the role that pharmacy benefit managers play in biosimilar adoption.
Conferences throughout 2022 shared new information on white bagging, the safety of biosimilar substitution, the use of a biobetter, and discussion around the role that pharmacy benefit managers (PBMs) play in biosimilar adoption.
5. NCCN Panel: How White Bagging Is Tied to High Drug Costs
A panel at the National Comprehensive Cancer Network (NCCN) annual meeting explored how white bagging, where PBMs require certain high-cost drugs to be shipped from their own specialty pharmacies to practices, is connected to higher drug costs. Oftentimes, the drugs involved in this practice may not arrive at clinics fully intact or a patient may require a dose change. The panelists also expressed how white bagging raises concerns about patient safety, as drugs may be sent to the wrong address or be delayed due to weather events. One panelist shared his worries about hospital liability when issues with delivery occur, such as the growing real-world situations within the community oncology space.
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4. ASCO Studies Assess Biosimilar Substitution, Adoption in Oncology Practices
At the American Society of Clinical Oncology (ASCO) annual meeting, researchers shared a poster on how biosimilar substitution led to significant reductions in aggregate provider risk in the Oncology Care Model (OCM), which suggested that continuing the practice could mitigate risks in value-based payment models for cancer. Another poster examined the financial impact of biosimilars within the OCM. Increased use of biosimilars within the US Oncology Network generated million of dollars in savings in the OCM, suggesting that continued adoption could increase savings to Medicare in the OCM.
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3. Celltrion’s Infliximab Biobetter Shows Significant Clinical Improvements Over Original Biosimilar Version
Celltrion Healthcare presented new data on Remsima SC, a biobetter based on the company’s infliximab biosimilar (Remsima), at the European Congress of Rheumatology’s annual meeting. The biobetter has been specially formulated to allow for subcutaneous (SC) administration in patients with rheumatic conditions, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The data showed that the biobetter produced better clinical outcomes, such as better remission rates and lower disease activity rates, than the original Remsima through week 54.
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2. Phase 3 Data Show Celltrion’s Bevacizumab Biosimilar Is Equivalent to Avastin in Lung Cancer
Another phase 3 study on Celltrion’s bevacizumab biosimilar (CT-P16) showed an objective response rate equivalent to the reference product (Avastin) in patients with metastatic or recurrent non-small cell lung cancer. The data from the double-blind, randomized, multicenter study was presented at the American Association of Cancer Research annual meeting. The analysis examined the drugs in 689 patients, 342 of whom received the biosimilar and the other 347 received the reference product. The researchers concluded that their results demonstrated clinical equivalence to between the drugs.
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1. Prior Authorization Panel Yields Insights Into Role of PBMs in Biosimilar Uptake
A session from the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit dove into recent dynamics between PBMs and practices over uptake of biosimilars and concerns about missing out on biosimilars savings if action isn’t taken. Most of the discussion focused on how prior authorization had increased administrative burdens on practices and the panelists suggested that the quest for rebates by PBMs could impact formulary placement for biosimilars. The panelists also touched on how some PBMs abuse step edits and create challenges in the diagnostic space.
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.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
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.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions
June 27th 2024Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life and infusion-related reactions in patients with lymphatic cancers.
ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars
June 24th 2024Two posters from the American Society of Clinical Oncology (ASCO) annual meeting look at Medicare reimbursement trends for originator and biosimilar biologics, as well as a combination therapy utilizing a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma.