FDA Tweaks Biosimilar Application Review Program

Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy

September 22nd 2021

The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.

FDA Delays Review of Alvotech's AVT02 Adalimumab Biosimilar Candidate

September 21st 2021

By Tony Hagen

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

FDA Approves First Ophthalmology Biosimilar: A Ranibizumab

September 20th 2021

By Tony Hagen

Byooviz (ranibizumab) was approved for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.

Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO

September 20th 2021

By Tony Hagen

Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.

Not So Different: How Biosimilar Companies Are Stepping Up Their Game to Compete Against Originators

September 19th 2021

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

Study: Zarxio More Costly Than Neupogen in Outpatient Hospital Setting

September 18th 2021

By Deana Ferreri, PhD

According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.

Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill

September 17th 2021

By Tony Hagen

Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.

Biocad's BCD-021 Bevacizumab Biosimilar Demonstrates Equivalence in NSCLC

September 17th 2021

By Tony Hagen

BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).

The Top 5 Biosimilar Articles for the Week of September 13

September 17th 2021

Here are the top 5 biosimilar articles for the week of September 13, 2021.

MIL60 Bevacizumab Biosimilar Candidate Demonstrates Equivalence in NSCLC

September 16th 2021

By Tony Hagen

MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.