The Center for Biosimilars

In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended PFS in untreated HER2-positive advanced gastric cancer patients. https://lnkd.in/eiHbuQPr

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations. The study, published in Advances in Therapy, analyzed responses from a panel of experts convened by the Americas Health Foundation (AHF) identified key steps to address these issues. Click the link to learn more: https://lnkd.in/eppqJyWk

Biosimilars Weekly Recap:  #5: Biosimilar CT-P13 shows promise for treating IBD! This study found it to be superior to a placebo for maintaining remission in patients with Crohn disease and ulcerative colitis.  #4: Biosimilars offer huge cost savings and treatment access, but policy changes are needed! Learn how to unlock their full potential. #3: Legal roadblocks to biosimilars in the US: Part 1 of a 3-part series explores the patent system and ongoing efforts to overcome these hurdles. #2: Part 2: Demystifying payer & PBM policies and how they impact biosimilar access. What does the future hold under a potential second Trump term? #1: Interchangeability: Key to biosimilar adoption. Part 3 dives into this crucial concept and its role in boosting access. To read more of these articles:  https://lnkd.in/evFyzXE2

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased! The study sought to determine whether these incentives affected prescribing patterns, particularly whether prescribers would be more inclined to use biosimilars over originators. Check out the results: https://lnkd.in/e4KdfeJT

Subscribe and check out the brand new newsletter from our friends at AJMC - The American Journal of Managed Care! The very first edition of Amplifying Managed Care News is live now!

Eye on Pharma: The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars. https://lnkd.in/esNKrnef

Sarfaraz K. Niazi, PhD proposes the development of a new association with rational scientific agenda, in his latest article. Niazi explains his disappointment of the high cost of development that is keeping biosimilars in the hands of big pharma, who aim to pursue high-market products to allow them to make sales projections that keep their stocks high. He suggests all companies currently engaged in developing biosimilars join hands with their regulatory and scientific teams to create a plan to push for rational regulatory guidelines. Read more of the proposal below: https://lnkd.in/eJFpMkKG

Can Global Policies to Boost Biosimilar Adoption Work in the US? On this episode of Not So Different, The Center for Biosimilars® celebrating Global Biosimilars Week—an annual advocacy campaign promoting the use of biosimilars worldwide orchestrated by the International Generics and Biosimilars Association. https://lnkd.in/emuxmr_E

In 2 randomized controlled trials of maintenance therapy for IBD, the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis. https://lnkd.in/e8i4ivTt

ICYMI: For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market. https://lnkd.in/eBuQQjQD