Future Biosimilar Trends, Challenges, and Opportunities
Sep 29, 2024 · Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
BioRationality: A Critical Analysis of Pfizer Views on Sustainability ...
As of December 2024, the FDA has approved 62 biosimilars (Figure 1). Companies that own biosimilars in the US are listed in Table 1. Pfizer, being the top company, published its views on the sustainability of biosimilars in an article titled “Stakeholder perspectives on …
Breaking Down Biosimilar Barriers: Interchangeability
Nov 14, 2024 · The Impact of the Interchangeability Designation on Patient Biosimilar Access. On June 20, 2024, the FDA published updated draft guidance titled “Consideration for Demonstrating Interchangeability with a Reference Product: Update.” The guidance describes considerations regarding a switching study, or studies, intended to support that a biological product is interchangeable with the ...
Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC …
ECCO 2024 took place from February 21 to February 24, 2024, in Stockholm, Sweden. Updated Celltrion Data on Subcutaneous Infliximab Therapy 1. Celltrion shared long-term data from its LIBERTY trials investigating the use of its subcutenous (SC) infliximab product (Zymfentra, Remsima SC) in Crohn disease (LIBERTY-CD) and ulcerative colitis (LIBERTY-UC).
FDA and Industry Experts Unpack Biosimilar Device Requirements
Oct 23, 2024 · At 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.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success …
Oct 16, 2024 · The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.
Center for Biosimilars®
The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
FDA Approves Epysqli as Second Soliris Biosimilar - Center for …
Jul 22, 2024 · The approval marked the second for an eculizumab biosimilar, following the May 2024 approval of Bkemv (eculizumab-aeeb). 2 Epysqli is also the eighth US biosimilar approval for Samsung Bioepis, following biosimilars for etanercept, infliximab, adalimumab, trastuzumab, bevacizumab, ranibizumab, aflibercept, and ustekinumab. 3 “The FDA approval of Epysqli as a biosimilar to Soliris marks an ...
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
Jul 17, 2023 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...
Podcasts - Center for Biosimilars
On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.