Here are the top 5 biosimilar articles for the week of January 15, 2024.
Number 5: Sarafraz 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.
Number 4: CVS Health has announced that it will remove AbbVie’s blockbuster immunosuppressive drug Humira from some of its preferred formulary drug lists in favor of more affordable biosimilar options for the drug. Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies, with branded and unbranded near copies of Humira manufactured by Biocon covered on some reimbursement lists.
Number 3: IQVIA’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.
Number 2: As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson (J&J) for restricting biosimilar ustekinumab competition, and Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
Number 1: The European Medicines Agency (EMA) granted marketing authorization to Uzpurvo, the first biosimilar to reference Stelara (ustekinumab). The biosimilar is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis.
To read all of these articles and more, visit centerforbiosimilars.com.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.