Ophthalmology

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.

The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.

Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.

The company has multiple biosimilar products on the worldwide market and in development; in 2019, it gained World Health Organization precertification for a trastuzumab biosimilar (Ontruzant).

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

This study of specialty drug spending looks beyond rebates to evaluate growth in spending from 2010 to 2017.

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

European investigators have derived a set of core principals for developing higher utilization of biosimilars.

Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

Sometimes the reference product exhibits pricing resistance against the competitive effect of biosimilars, according to a Pharmaceutical Strategies Group report.

The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.