News

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

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.

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.

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.

Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

Here are the top 5 biosimilar articles from the American College of Rheumatology (ACR) Convergence 2020.

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them.

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.

Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.

Here are the top 5 biosimilar articles for the week of November 16, 2020.

Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.

Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.

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.

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

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.

Investigators looked at adherence in patients who switched from reference infliximab during treatment for rheumatologic and gastrointestinal treatment.

The court must decide whether Congress’ setting the shared responsibility payment to $0 means that the entire Affordable Care Act (ACA) statute is now unconstitutional.

In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.

Revance’s fight to compete in the onabotulinumtoxinA (Botox) market hit a snag when its drug candidate failed to meet the efficacy primary end point in a study.

Here are the top 5 biosimilar articles for the week of November 9, 2020.

Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.

Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.

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.