Study Highlights Role of Health Plan Type in Biosimilar Adoption
January 16th 2024A study examining biosimilar uptake patterns within different health insurance plans found that low-flexibility plans, such as health maintenance organizations and exclusive provider organizations, were more likely to initiate biosimilar therapies than more flexible plans.
FDA Approves First Biosimilar for Neulasta Onpro
January 15th 2024The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Proposed Bevacizumab Biosimilar Demonstrates Clinical Equivalence to Avastin in NSCLC
January 13th 2024The proposed bevacizumab biosimilar BAT1706 (Bio-Thera Solutions) demonstrated equivalence to the reference product (Avastin) in a phase 3 comparative efficacy trial in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).
Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars
January 11th 2024As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe
January 10th 2024IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.
BioRationality: An Analysis of the Future of Biosimilars Through the Eyes of History
January 8th 2024Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.
Posters Show Efficacy for Combination Therapies With Trastuzumab Biosimilars in Breast Cancer
January 4th 2024Posters from San Antonio Breast Cancer Symposium 2023 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.
Developers’ Perspective on Streamlining the Biosimilar Development Process
January 2nd 2024The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.
The Top 5 Most-Read Rheumatology Stories of 2023
January 1st 2024The top 5 most-read rheumatology stories of 2023 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara and Enbrel to the list of originators up for Medicare price negotiation.
The Top 5 Most-Read Conference Stories of 2023
December 28th 2023The top 5 most-read conference stories of 2023 recapped some of big biosimilar takeaways from this year’s conferences, including insight into how geopolitics will impact the industry, efforts from government agencies, and strategies to increase biosimilar uptake.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders
December 18th 2023Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.