Ophthalmology

Study: Ranibizumab Biosimilar Found Safe, Effective in Infants With Retinopathy

April 8th 2023

By Skylar Jeremias

Article

A retrospective study from India found that Razumab, a ranibizumab biosimilar, was safe and effective to use in infant patients with retinopathy of prematurity. This is the first analysis assessing the clinical outcomes associated with the biosimilar in this population.

Ximluci, a Lucentis Biosimilar, Launches in Europe

April 4th 2023

By Skylar Jeremias

Article

STADA Arzneimittel and Xbrane Biopharma announced the launch of Ximluci, a ranibizumab biosimilar referencing Lucentis approved to treat ophthalmic conditions, across the European Union.

Getting Ophthalmic Biosimilars to Market Continues to Prove Difficult

March 27th 2023

By Maggie L. Shaw

Article

Representatives from Magellan Rx Management provided a detailed overview of current treatment options in ophthalmology and the impact that biosimilars could have during a session at AMCP 2023.

A Long Time Coming: Dr Sophia Humphreys Details What’s Coming Down the Biosimilar Pipeline

March 23rd 2023

By Skylar Jeremias

Article

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

Phase 3 Study Demonstrates Comparable Safety, Efficacy Between Ranibizumab Biosimilar, Lucentis for nAMD

March 10th 2023

By Justina Petrullo

Article

Comparable safety and efficacy were found between biosimilar FYB201 compared with reference ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD).

Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin

March 9th 2023

By Skylar Jeremias

Article

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

Sandoz' Dr Sonia Oskouei Predicts How Adalimumab Biosimilars Can Help Biosimilar Uptake Overall

February 12th 2023

By Skylar Jeremias

Article

Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, foreshadows how the US market introduction of adalimumab biosimilars could influence future biosimilar entrances and discusses why educational efforts need to be tailored to different specialties and stakeholders.

Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab Study

February 8th 2023

By Skylar Jeremias

Article

Formycon shared positive data on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

January 29th 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

Phase 3 Trial Suggests Equivalence Between Biosimilar CKD-701 and Reference Ranibizumab in nAMD

January 28th 2023

By Deana Ferreri, PhD

Article

A phase 3 analysis found that CKD-701, a ranibizumab biosimilar candidate developed by CKD Limited, has comparable clinical efficacy and safety with the reference product (Lucentis) in patients with neovascular age-related macular degeneration (nAMD).