Ophthalmology

Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.

Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

Defining biosimilar use in the United States as "sluggish," Juliana Reed, MS, said employers have to get involved.

Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.

Biosimilars have improved access to health care in India, but many effective new drugs are high priced and patented, and authors of a new study recommend interventions to make these available, too.

Vizient predicts that drug price inflation, partly due to the coronavirus disease 2019 (COVID-19), will be 3.29% in 2021 and is banking on biosimilars to help contain the rising cost of medication, it said in a comprehensive review for its member health companies.

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

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 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.

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

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

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

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.

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.

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.

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.

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.

Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.

Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.

Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity in infants.

A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.

Anti–vascular endothelial growth factor therapy is the standard of care for the first-line treatment of macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and a number of therapeutic options are available, including aflibercept, ranibizumab, and off-label bevacizumab.

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

During this week’s Association for Research in Vision and Ophthalmology 2019 Annual Meeting, researchers presented new findings on the utility—and the delivery—of bevacizumab in eye disorders.

Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.