Regulatory

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

November 21st 2024

By The Center for Biosimilars Staff

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

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.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data

November 19th 2024

By Skylar Jeremias

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

Can Global Policies to Boost Biosimilar Adoption Work in the US?

November 17th 2024

On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.

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.

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.

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

October 25th 2024

By Skylar Jeremias

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 23rd 2024

By Skylar Jeremias

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 23rd 2024

By Skylar Jeremias

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.

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

October 21st 2024

By Sarfaraz K. Niazi, PhD

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.