Development

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

November 21st 2024

By Skylar Jeremias

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

BioRationality: A Proposal to Create a New Association With Rational Scientific Agenda

November 18th 2024

By Sarfaraz K. Niazi, PhD

Breaking Down Biosimilar Barriers: Interchangeability

November 14th 2024

By Dracey Poore

Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

November 5th 2024

By Skylar Jeremias

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?

November 4th 2024

By Sarfaraz K. Niazi, PhD

The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.

Biosimilars Development Roundup for October 2024—Podcast Edition

November 3rd 2024

By Skylar Jeremias

On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.

Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

October 31st 2024

By Skylar Jeremias

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.

Biosimilars Development Roundup: October 2024

October 31st 2024

By Skylar Jeremias

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 30th 2024

By Skylar Jeremias

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 29th 2024

By Skylar Jeremias

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.