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Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19....

Coherus Biosciences announced positive results from a randomised, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device compared to the currently market...

Opthea announced the enrolment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration has opened in Europe.

Celltrion presented two new data sets on the use of Remsima® SC (biosimilar infliximab) in inflammatory bowel disease in a poster presentation at United European Gastroenterology Week 2021.

A new study published in Cancer Communications reported that Boan Biotechnology’s LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to Avastin® in patients with advanced or recurrent non-squamous NSCLC.

Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connecte...