Policy

Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

November 7th 2024

By Skylar Jeremias

Article

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

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

November 4th 2024

By Sarfaraz K. Niazi, PhD

Article

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

Article

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

Article

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.

How Policy Reforms in PBM Systems Could Change the Adalimumab Market

October 28th 2024

By Skylar Jeremias

Article

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

Veterans’ Experience With Infliximab Biosimilars for IBD Treatment

October 26th 2024

By Deana Ferreri, PhD

Article

A study of the Veterans Health Administration detailed their experience with infliximab biosimilars in a population of patients with inflammatory bowel disease (IBD) who were naive to infliximab.

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

October 25th 2024

By Skylar Jeremias

Article

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

Article

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

Article

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 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.