Center for Biosimilars®
网页Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
Future Biosimilar Trends, Challenges, and Opportunities
网页15 小时之前 — Future Biosimilar Trends, Challenges, and Opportunities. Ivo Abraham, PhD, RN, University of Arizona Cancer Center, explains how biosimilars are becoming more accessible but face challenges like price erosion and potential shortages. Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at …
Patient-Reported Outcomes Similar Between Adalimumab-admb, …
网页1 天前 — The trial found similar efficacy and safety of the adalimumab biosimilar Cyltezo (adalimumab-admb; Boehringer Ingelheim) and the reference product (Humira) in patients with moderate to severe rheumatoid arthritis (RA). “Similar substantial benefits across a range of patient-reported outcomes” were reported in VOLTAIRE-RA participants ...
Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; …
网页3 天之前 — Celltrion USA announced an agreement with Cigna Healthcare and Express Scripts to expand patient access to Zymfentra (infliximab-dyyb), the only FDA-approved subcutaneous infliximab. 2 Effective August 1, 2024, Zymfentra will be listed as a preferred medication on Cigna’s medical formulary, covering 16.1 million insured lives.
News - Center for Biosimilars
网页2024年9月23日 — STADA Credits Biosimilar Expansion for Profitable First Half of 2024. Skylar Jeremias. September 15th 2024. German biosimilar manufacturer STADA Arzneimittel reported a 9% revenue increase in the first half of 2024, with over €2 billion in sales, driven in part by biosimilar successes and new product launches.
The Role of Risk-Sharing Models in Biosimilar Adoption
网页2024年9月22日 — The risk is financial as opposed to in other treatment areas or newer treatment areas, where the risk is also clinical—for instance, a new monoclonal antibody that gets approved. Ivo Abraham, PhD, RN, University of Arizona Cancer Center, analyzes the need for innovative risk-sharing models to promote biosimilar development and utilization.
Immunology - Center for Biosimilars
网页Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars. A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond. Biosimilars Immunology Roundup for July 2023—Podcast Edition. Biosimilars Immunology Roundup for May 2023—Podcast Edition.
Learning the Lingo of Biologics and Biosimilars Is Critical
网页2024年7月31日 — The most complex biologics first entered the market in the 1980s and 1990s, and for this reason, many of their patents are expiring. 1 The concept of biosimilars was a rational idea that loosely mimicked the idea of generic drugs. 2 However, because biologics are large, 3-dimensional, complex molecules, it …
Understanding the Risks, Opportunities, and Prospects of Biosimilars …
网页2020年2月14日 — Entering 2020, we have the opportunity to take a moment, look back, and reflect on the lessons learned of the previous decade with regard to biosimilars. The road to a successful biosimilars market has been anything but straightforward. With complications including a slow rate of approval, extended delays in product launches due to patent ...
A 2021 Recap of Biosimilars: Approvals, Legislation, and What’s to …
网页2022年2月14日 — After a slow 2020 for biosimilars, 2021 picked up the pace a bit, with more approvals, some updated guidance, new potential legislation, and greater uptake for marketed products, suggesting that the United States is shifting focus from pushing COVID-19 treatments back to growing the biosimilars industry, speakers in …
- 某些结果已被删除
跳至内容