Regulatory

The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur

December 17th 2023

By Skylar Jeremias

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

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

December 12th 2023

By Skylar Jeremias

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.

Cencora's Brian Biehn Forecasts Big Changes for the US Biosimilar Space

December 10th 2023

By Skylar Jeremias

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

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

December 6th 2023

By Skylar Jeremias

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.

BioRationality: Efficacy Testing and Interchangeability of Biosimilar Remains a Dogma for Most

December 4th 2023

By Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.

Confusion Persists Around the Interchangeability Designation for Biosimilars

November 23rd 2023

By Gillian Woollett, MA, DPhil

The legal and common uses of “interchangeability” continue to be conflated.

Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar

November 22nd 2023

By Skylar Jeremias

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

BioRationality: FDA Publishes Results of First Meta-Analysis to Conclude All Biosimilars Are Interchangeable

November 20th 2023

By Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.

Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle?

November 16th 2023

In partnership with The Center for Biosimilars®, the International Generic and Biosimilar Association hosted a live webinar, where panelists gathered from around the globe to discuss benefits as well as major barriers and accessibility challenges associated with oncology biosimilars worldwide.

Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe

November 16th 2023

By Skylar Jeremias

In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.