Ophthalmology

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.

A diverse panel from practice, payer, and wholesale perspectives convened at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference to hash out one of the hottest issues in biosimilar availability right now.

It’s same old, same old when it comes to pharmacy benefit manager (PBM) contracts despite much touted reforms, authors of a review contend.

Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.

Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

Defining biosimilar use in the United States as "sluggish," Juliana Reed, MS, said employers have to get involved.

Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.

Biosimilars have improved access to health care in India, but many effective new drugs are high priced and patented, and authors of a new study recommend interventions to make these available, too.

Vizient predicts that drug price inflation, partly due to the coronavirus disease 2019 (COVID-19), will be 3.29% in 2021 and is banking on biosimilars to help contain the rising cost of medication, it said in a comprehensive review for its member health companies.

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

Polpharma Biologics said it is close to finishing its integration of Bioceros, a company it acquired 4 years ago. The acquisition gave Polpharma an advanced cell line development platform, and with a bioreactor facility nearing completion, the company said it is poised for growth.

A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

Xbrane Biopharma said it needs a new lab and headquarters because of rapid growth and ambitious plans for biosimilar development.

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.