Policy

Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships

June 6th 2024

By Skylar Jeremias

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Biosimilars Council Position Paper Calls for End to Clinical Efficacy Trials for Biosimilars

June 4th 2024

By Skylar Jeremias

Article

In a position paper from the Biosimilars Council, the organization points to evidence showing that clinical efficacy trials are a major barrier to biosimilar access in the US, calling for the FDA to change its policies to remove them in favor of other comparators.

Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches

May 14th 2024

By Skylar Jeremias

Article

The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.

Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability

May 9th 2024

By Skylar Jeremias

Article

As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.

BioRationality—FDA’s Guidance on Promotional Labeling

May 6th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.

Biosimilars Policy Roundup for April 2024—Podcast Edition

May 5th 2024

By Skylar Jeremias

Podcast

On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars

May 2nd 2024

By Skylar Jeremias

Article

Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.

Biosimilars Policy Roundup: April 2024

May 1st 2024

By Skylar Jeremias

Article

April brought 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability

April 30th 2024

By Skylar Jeremias

Article

During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.

Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar

April 29th 2024

By Skylar Jeremias

Article

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.