Ophthalmology

Eye on Pharma: High-Strength Trastuzumab Biosimilar; Originator Coverage Removals; CHMP Aflibercept Opinion

October 3rd 2024

By Skylar Jeremias

The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.

FDA Approves Pavblu for Retinal Conditions

September 17th 2024

By Skylar Jeremias

Amgen’s Pavblu (aflibercept-ayyh) is the fifth biosimilar referencing Eylea (aflibercept) to be approved for American patients with retinal diseases.

Biosimilar CT-P42 Demonstrates Equivalence to Aflibercept for DME

August 20th 2024

By Cameron Santoro

Biosimilar CT-P42 demonstrated comparable efficacy, safety, and tolerability to reference aflibercept in treating diabetic macular edema (DME).

FDA Approves Biosimilar Enzeevu for Eye Conditions

August 12th 2024

By Skylar Jeremias

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data

July 10th 2024

By Skylar Jeremias

The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.

Ahzantive Receives FDA Approval as New Eylea Biosimilar

July 1st 2024

By Skylar Jeremias

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars

May 27th 2024

By Skylar Jeremias

Alvotech and Teva have launched Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.

FDA Approves First Eylea Biosimilars

May 20th 2024

By Skylar Jeremias

The FDA approved the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions.

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report

May 19th 2024

By Skylar Jeremias

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth

March 14th 2024

In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.