Pharmacokinetic and Pharmacodynamic Equivalence of Biocon’s Proposed Biosimilar Insulin-R to Humulin-R

January 17, 2022

Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.

Wayne Winegarden, PhD Discusses Which Insurance Type He Expects Will Have the Greatest Biosimilar Savings

January 16, 2022

International Biosimilars Trade Group Appoints New Leadership for 2022

January 15, 2022

The Top 5 Biosimilar Articles for the Week of January 10

January 14, 2022

Michigan Trade Group Outlines Best Practices for Biosimilar Adoption

January 13, 2022

In Canada, More Mandatory Switching

December 23rd 2021

By Tony Hagen

Article

In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.

The Top 5 Biosimilar Business Stories of 2021

December 23rd 2021

Article

Business stories about Celltrion, the potential for mRNA biosimilar vaccines, and Amgen's biosimilars overview topped the rankings for reader popularity in 2021.

The Top 5 Biosimilar Regulatory Stories of 2021

December 22nd 2021

Article

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

2021 Was an "Inflection Year" for Biosimilars

December 21st 2021

By Tony Hagen

Article

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

FDA Approves Yusimry, the Seventh Adalimumab Biosimilar

December 21st 2021

By Tony Hagen

Article

Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.

AbbVie Returns to Court in Effort to Block Alvotech Adalimumab Biosimilar Candidate

December 20th 2021

By Tony Hagen

Article

After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.

Panelists Discuss Regulatory Perspective on Biosimilars

December 20th 2021

By Tony Hagen

Article

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Molecular Selection Boosts pCR Rate in Early Breast Cancer Trial

December 20th 2021

By Tony Hagen

Article

Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.

Wayne Winegarden, PhD, Discusses the Value of an Interchangeable Designation for Adalimumab Biosimilars

December 19th 2021

By Skylar Jeremias

Video

An economist weighs in on whether interchangeable status will help adalimumab biosimilars succeed.

SB12 Eculizumab Biosimilar Candidate Demonstrates PK, PD Equivalence in Phase 1 Trial

December 18th 2021

By Tony Hagen

Article

In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.