Policy

FTC Releases Second Report on PBMs Meddling in Generic Drug Markets

January 19th 2025

By Skylar Jeremias

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Improving Biosimilar Access Through Global Regulatory Convergence

January 15th 2025

By Skylar Jeremias

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

January 9th 2025

By Cameron Santoro

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

BioRationality: What’s Wrong With the Indian CDSCO Biosimilar Guidelines?

January 7th 2025

By Sarfaraz K. Niazi, PhD

Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

January 2nd 2025

By Skylar Jeremias

To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

The Top 5 Most-Read Policy Articles of 2024

December 28th 2024

By Skylar Jeremias

The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.

How Vertical Integration Drives Innovation and Access in Biosimilars

December 27th 2024

By Skylar Jeremias

Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.

Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access

December 22nd 2024

By Skylar Jeremias

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.

13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching

December 18th 2024

By Skylar Jeremias

A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.

Strategies for Improving Biosimilar Access and Utilization

December 15th 2024

By Skylar Jeremias

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discussed barriers to biosimilar adoption and highlighted strategies such as physician education, streamlined implementation, payer collaboration, and patient engagement to improve access, reduce costs, and enhance adherence to biologic therapies.