November 28, 2020
Tony Hagen
A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.
November 25, 2020
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.
November 24, 2020
Skylar Jeremias
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.
November 18, 2020
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.
November 17, 2020
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
November 16, 2020
The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.
November 11, 2020
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.
November 9, 2020
Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.
November 5, 2020
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).
