Regulatory

FDA Tweaks Biosimilar Application Review Program

September 25th 2021

By Tony Hagen

Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.

Cardinal Health Biosimilars Expert Discusses Dynamics of Byooviz Launch

September 24th 2021

The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.

AAO Reacts to Ranibizumab Biosimilar Approval

September 23rd 2021

The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.

Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings

September 22nd 2021

By Tony Hagen

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

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.

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.

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.