Two More Pairs of Denosumab Biosimilars Enter US Market

Eye on Pharma: Another CRL for Alvotech; Cimerli’s Growing Market Share; BBCIC Awarded Grant

October 19th 2023

By Skylar Jeremias

Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).

Navigating Data Integrity for Generic Drug Approvals

October 18th 2023

By Ayaaz Hussain Khan, PhD

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

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

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.