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Latest Conference Articles
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
Skylar Jeremias
October 31 2024
By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
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Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
Skylar Jeremias
October 25 2024
At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
Skylar Jeremias
October 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.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
Skylar Jeremias
October 23 2024
At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
Unifying Standards: The Need for Streamlined Biosimilar Development
Skylar Jeremias
October 22 2024
At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability
Skylar Jeremias
October 22 2024
At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.
EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions
Skylar Jeremias
June 27 2024
Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life and infusion-related reactions in patients with lymphatic cancers.
ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars
Skylar Jeremias
June 24 2024
Two posters from the American Society of Clinical Oncology (ASCO) annual meeting look at Medicare reimbursement trends for originator and biosimilar biologics, as well as a combination therapy utilizing a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma.
EHA Poster Shows Transfusion Avoidance Rates Were Comparable Between Eculizumab Biosimilar, Soliris
Skylar Jeremias
June 15 2024
A poster from the European Hematology Association’s (EHA) 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).