Development

Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim Found in Clinical Studies

November 4th 2023

By Deana Ferreri, PhD

Article

Researchers of a literature review found similar safety profiles between a biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.

Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and Bioparallels

October 30th 2023

By Ivo Abraham, PhD

Article

In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.

Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future

October 25th 2023

By Skylar Jeremias

Article

As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.

Navigating Data Integrity for Generic Drug Approvals

October 18th 2023

By Ayaaz Hussain Khan, PhD

Article

Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data.

Review: Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim in Clinical Studies

October 17th 2023

By Deana Ferreri, PhD

Article

Researchers of a literature review found similar safety profiles between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.

BioRationality—A DMF Route to Biosimilars: CDMOs Can Make Biosimilars Accessible and Affordable

October 16th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.

Dr Stephen Hanauer: Why More Studies Assessing Adalimumab Biosimilars in Gastro Conditions Are Needed

October 15th 2023

By Skylar Jeremias

Video

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.

Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate

October 9th 2023

By Skylar Jeremias

Article

At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

Webinar: Experts Discuss Avenues to Improve Biosimilar Development Efficiency

October 4th 2023

By Skylar Jeremias

Article

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues

October 3rd 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.