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Biosimilars Development Roundup: October 2024

October 31, 2024

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.

Enhancing Adoption of Infused Biosimilars for a Sustainable Future

October 30, 2024

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.

Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry

October 29, 2024

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.

Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf

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

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

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

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

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.

Addressing Hesitance in Biosimilar Adoption

October 20, 2024

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.