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October 31, 2024
Article
In October, the GRx+Biosims conference included discussions on data transparency, artificial intelligence, and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
October 30, 2024
Article
An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
October 29, 2024
Article
Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
October 28, 2024
Article
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 25, 2024
Article
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 23, 2024
Article
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.
October 23, 2024
Article
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 22, 2024
Article
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.
October 22, 2024
Article
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explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.
October 20, 2024
Video
Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.