October 31st 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.
October 28th 2024
Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.
October 25th 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.
October 23rd 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.
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.
October 22nd 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.
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explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.
December 20th 2021
A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.
November 10th 2021
Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.
November 8th 2021
Janet Woodcock, MD, acting commissioner of the FDA, said the agency is meeting with biosimilar developers for biosimilars for 46 reference products.
