Dermatology

Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars

January 11th 2024

By Skylar Jeremias

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

EMA Approves First Ustekinumab Biosimilar, Uzpruvo

January 10th 2024

By Skylar Jeremias

Article

The European Medicines Agency (EMA) has granted marketing authorization to the first ustekinumab biosimilar, STADA Arzneimittel and Alvotech’s Uzpruvo.

IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe

January 10th 2024

By Skylar Jeremias

Article

IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

Biosimilar SB5 Matches Originator in Safety, Efficacy for Inflammatory Diseases After Switching

January 3rd 2024

By Cameron Santoro

Article

Adults with inflammatory diseases maintained disease control when transitioning from originator adalimumab (Humira) to biosimilar SB5 in a pan-European study.

A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond

December 31st 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

Eye on Pharma: Hadlima Interchangeability; CHMP Green Lights Ustekinumab; Biosimilars Forum Supports Draft Legislation

December 12th 2023

By Skylar Jeremias

Article

The FDA agreed to review an application for Hadlima (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for a Senate Finance Committee’s draft legislation promoting biosimilars.

Factors Physicians Should Consider When Selecting an Adalimumab Biosimilar

December 9th 2023

By Deana Ferreri, PhD

Article

A review article discussed the characteristics of the available adalimumab biosimilars to help clinicians navigate the various treatment options with their patients.

Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab

December 6th 2023

By Skylar Jeremias

Article

Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.

Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions

December 2nd 2023

By Deana Ferreri, PhD

Article

A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.

HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain

November 28th 2023

By Skylar Jeremias

Article

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.