Policy

Unifying Standards: The Need for Streamlined Biosimilar Development

October 22nd 2024

By Skylar Jeremias

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.

GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability

October 22nd 2024

By Skylar Jeremias

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explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered

October 21st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

Addressing Hesitance in Biosimilar Adoption

October 20th 2024

By Skylar Jeremias

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.

Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans

October 17th 2024

By Skylar Jeremias

Article

Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.

Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges

October 16th 2024

By Skylar Jeremias

Article

The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.

IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics

October 14th 2024

By Skylar Jeremias

Article

During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.

Sandoz Report: A Unified Approach to Overcoming Drug Shortages

October 10th 2024

By Skylar Jeremias

Article

A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.

Duke Publishes Recommendations for Developing CGT Biosimilars

October 9th 2024

By Skylar Jeremias

Article

Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.

BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

October 7th 2024

By Sarfaraz K. Niazi, PhD

Article

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.