Ophthalmology

Following lackluster experience with biosimilar marketing in the United States, Merck moves forward with spinoff plan.

Pfizer said it has made a business decision to cease production of biosimilars at a $350 million plant it built recently in Hangzhou, China.

Alvotech closes on $35 million in funding, and Samsung Bioepis gets closer to marketing an adalimumab biosimilar. Alvotech's planned high-tech expansion is pictured.

The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Alteogen is among a number of contenders vying to bring aflibercept biosimilars to market. Key patents on the originator begin to expire in 2023.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer.

Gary H. Lyman, MD, PhD, provides an expert overview on overcoming the challenges of discussing biosimilars with patients.

Patient characteristics are predictive of whether a switch to a biosimilar is likely to be accepted, investigators found.

In its annual drug price guide, Vizient predicts that US annual adalimumab (Humira) revenues could reach $24 billion before biosimilars enter the marketplace.

The study of originator infliximab and SB2 used nurses as the first point of contact when educating patients, relying partly on patient trust in these health care professionals.

It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.

Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.

Biosimilars will be the cornerstone for a leap into biologics development and commercialization, according to the CEO of Prestige Biopharma. Also, Innovent Biologics reaches a marketing agreement.

The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.

Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.

Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.

China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.

Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.

Samsung Bioepis hopes to gain regulatory approval for a denosumab biosimilar referencing Prolia. The trial will focus on women with postmenopausal osteoporosis.

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach.

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.