Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

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

October 16th 2023

By Sarfaraz K. Niazi, PhD

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

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.

Prince Edward Island Announces New Biosimilar Switching Policy

October 14th 2023

By Skylar Jeremias

Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.

The Top 5 Biosimilar Articles for the Week of October 9

October 13th 2023

By Justina Petrullo

Here are the top 5 biosimilar articles for the week of October 9, 2023.

Varying Biosimilar Policies Create Uneven Market Sustainability Across Nations

October 12th 2023

By Skylar Jeremias

An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.

Review: No Safety, Efficacy Issues Found in Patients Who Switched From Originators to Biosimilars

October 11th 2023

By Justina Petrullo

No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.

What is key to achieving a long-term sustainable biosimilars market?

October 11th 2023

Pfizer Global Biosimilars Commercial Lead, Roman Irsiegler, gives his thoughts on why a sustainable biosimilars market is critical for the healthcare industry, and what stakeholders can do to achieve it.

How can we achieve a long-term sustainable biosimilars market?

October 11th 2023

Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart

October 10th 2023

By Skylar Jeremias

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate

October 9th 2023

By Skylar Jeremias

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).