Ophthalmology

Webinar: How Biosimilar Rebates Shape Payer Policies, Provider Behavior

July 16, 2020

Tony Hagen

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

Polpharma Biologics Moves Forward With Bioceros Integration

July 16, 2020

Skylar Jeremias

Polpharma Biologics said it is close to finishing its integration of Bioceros, a company it acquired 4 years ago. The acquisition gave Polpharma an advanced cell line development platform, and with a bioreactor facility nearing completion, the company said it is poised for growth.

Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar

June 30, 2020

Skylar Jeremias

A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

Xbrane Will Move Into Larger Biotech Lab, Headquarters

June 8, 2020

Skylar Jeremias

Xbrane Biopharma said it needs a new lab and headquarters because of rapid growth and ambitious plans for biosimilar development.

FDA Releases Framework for Assessing Gene Therapies in Anticipation of Future Filings

January 29, 2020

The Center for Biosimilars Staff

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

Meta-Analysis Finds No Increased Mortality for Patients Treated With Intravitreal Anti-VEGFs

December 30, 2019

Kelly Davio

Intravitreal injection with anti–vascular endothelial growth factor (anti-VEGF) drugs has represented a major step forward for patients with retinal diseases, and the upcoming biosimilars market for these drugs—including aflibercept and ranibizumab, as well as off-label bevacizumab—is beginning to take shape. However, there have been some lingering concerns about the safety of these drugs, as increased mortality has been reported after anti-VEGF treatment in the general population.

Canadian Organizations Gather Stakeholders to Stimulate Biosimilar Acceptance

December 18, 2019

The Center for Biosimilars Staff

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

Switching to Anti-TNF Biosimilars Is a Feasible Treatment Choice in Uveitis, Study Finds

December 12, 2019

Given the availability of biosimilars of infliximab, etanercept, and adalimumab in multiple markets worldwide, and given the cost savings associated with the biosimilars, there is growing interest in switching patients receiving maintenance treatment for uveitis to these biosimilar options, but data in switching patients with uveitis have been limited.

Anti-VEGFs May Provide Substantial Economic Value to Patients and Society in Treating Wet AMD

November 18, 2019

The Center for Biosimilars Staff

The field of biosimilar contenders for anti–vascular endothelial growth factor (anti-VEGF) therapies is taking shape, with biosimilar developer Coherus seeking to launch its ranibizumab biosimilar in 2021 and Samsung Bioepis having reached a commercialization agreement for 2 biosimilar anti-VEGFs of its own. Last week, a study published in JAMA Ophthalmology supported the use of anti-VEGF agents in wet age-related macular degeneration (AMD), saying that, though these drugs are costly, they may provide substantial economic value to both patients and society.

In Macular Edema, No Difference in VALS or CST at Month 24 for Those Treated With Bevacizumab or Aflibercept

November 9, 2019

The Center for Biosimilars Staff

Researchers report that there were no differences in visual acuity letter score (VALS) and central subfield thickness (CST) outcomes at month 24 between patients treated with bevacizumab and those treated with aflibercept in the SCORE2 study.