Ophthalmology

Long-term results comparing ranibizumab biosimilar SB11 vs reference ranibizumab (Lucentis) on neovascular age-related macular degeneration (nAMD) support biosimilarity between the treatments.

The ranibizumab biosimilar XSB-001 (Ximluci) demonstrated biosimilarity to the originator (Lucentis) in a phase 3 trial in neovascular age-related macular degeneration (nAMD).

At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).

Biosimilar ranibizumab showed similar efficacy and safety in a recent study of the eyes of Indian patients with neovascular age-related macular degeneration.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.

A real-world study in India compared the ranibizumab biosimilar Razumab to the originator (Lucentis) in patients with polypoidal choroidal vasculopathy (PCV), finding that the biosimilar had comparable clinical outcomes.

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.

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

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.

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.

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

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.

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.

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.

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).

As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

The United Kingdom has approved STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.

Michael Chiang, MD, director of the National Eye Institute, discusses how his team is working to instill greater confidence in ophthalmology biosimilars among wary ophthalmologists.

Coherus Biosciences has acquired an aflibercept biosimilar; the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar; Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.

Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, explains what health organizations and health systems can do to better manage and instill confidence in biosimilars.

Biosimilar news in ophthalmology throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.

The European Union has approved a third biosimilar referencing Lucentis (ranibizumab), STADA Arzneimittel and Xbrane BioPharma’s Ximluci, for the treatment of retinal conditions.

Abstracts presented at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting explored the adoption of infliximab biosimilars, utilization patterns of bevacizumab biosimilars in ophthalmology and oncology settings, and the budget impact of transferring patients to a natalizumab biosimilar from the originator.

Two studies presented at the American Academy of Ophthalmology (AAO) annual meeting in Chicago, Illinois, demonstrated the impact that a ranibizumab biosimilar (SB11; Byooviz) can have on patient outcomes.

Speakers during a LinkedIn Live panel discussion expressed a dire need for all stakeholders to work together to increase education efforts, provide clarity on safety and interchangeability, and encourage adoption of biosimilars in ophthalmology.

Genentech and Roche have voluntarily recalled their ophthalmology biobetter, Susvimo, an ocular implant for ranibizumab injection, in the United States for a possible leakage issue.

Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Amneal Pharmaceuticals filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.