Ophthalmology

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

The top 5 most-read ophthalmology stories of 2023 concerned clinical results, approvals, and launches for ranibizumab and aflibercept biosimilars.

Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.

A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

Between 3 regulatory approvals, 2 complete response letters, and new data and industry insights, October brought a number of business updates that have the potential to impact the entire US biosimilar industry.

As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.

Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.

Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).

At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

In Biocon’s latest quarterly earnings report, the company revealed that sales for its biosimilars portfolio rose 106% compared with the same time frame the year prior.

In STADA Arzneimittel’s first half of 2023 earnings report, the company disclosed double-digit growth, suggesting that it could see profits hit an all-time high by the end of the year.

Ranibizumab biosimilar was found to be the most cost-effective for neovascular age-related macular degeneration (nAMD), according to a recent Japanese study.

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

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.