Asembia: Payers More Likely to Prefer Multiple Biosimilars for the Same Reference Product
May 4th 2023In a panel at the 2023 Asembia Specialty Pharmacy Summit, speakers presented on the payer perspective regarding biosimilars, including that they feel comfortable preferring multiple biosimilars for the same reference product and are looking for interchangeability designations.
Despite Concerns Over Extrapolation, Bevacizumab Biosimilars Are Widely Used in mCRC
May 3rd 2023A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.
Samsung Bioepis Shares 1-Year Phase 3 Results for Eylea Biosimilar
May 2nd 2023At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).
Biosimilars Rheumatology Roundup for April 2023—Podcast Edition
April 30th 2023On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.
Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo Effect
April 27th 2023Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.
Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval
April 26th 2023Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.
Dr Andre Harvin Explains His Excitement for Neulasta Onpro Biosimilars
April 23rd 2023Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, expressed staunch belief that biosimilars referencing Neulasta Onpro, the on-body injector version of reference pegfilgrastim, are one of the most exciting things coming to the supportive cancer care space.
SB11 Demonstrates Biosimilarity to Lucentis in Long-term Study in nAMD
April 22nd 2023A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.
Multiple Infliximab Biosimilar Switches Appear Safe, Effective for Patients With IBD
April 20th 2023A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.
Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars
April 19th 2023A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
BioRationality: FDA Final Guidance on Continuous Manufacturing—A Boon for Biosimilars
April 17th 2023The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.
Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars
April 16th 2023What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.
Real-World Study Suggests Comparable Efficacy Between Biosimilar Razumab and Originator in PCV
April 15th 2023A real-world study in India compared the ranibizumab biosimilar Razumab to the originator (Lucentis) in patients with polypoidal choroidal vasculopathy (PCV), finding that the biosimilar had comparable clinical outcomes.
FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar
April 14th 2023In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.
Real-world Data Show Interchangeability of Rituximab Biosimilar
April 11th 2023A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was safe for patients and did not result in a change in adverse events.
Christine Baeder Discusses the Future of the Biosimilar Industry, Insulins
April 9th 2023Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM), Christine Baeder discussed what she believes the future holds for biosimilars, good and bad, and the questions that still surround the insulin price cap.