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Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.

Coherus publishes phase 3 studies on proposed biosimilar adalimumab, CHS-1420.

Hexal/Parexel publishes results of PK, immunogenicity and safety studies relating to proposed adalimumab biosimilar GP2017. 

Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.

Celltrion releases phase III results for switching studies comparing Biosimilar infliximab CT-P13 (marketed by Celltrion as Remsima® and by Pfizer as Inflectra®) and Remicade®, and phase I (open label) studies for sub-cutaneous infliximab.

Sandoz’s (refiled) EU application for biosimilar pegfilgrastim accepted for regulatory review by EMA. Sandoz received an FDA rejection in Jul 2016, and withdrew its earlier EMA application in Jan 2017.

Russian biosimilars company Biocad succeeds in Russian patent challenge relating to the use of rituximab for RA, and announces intention to launch in EU.

Genentech files a further suit under seal (District of Delaware) against Amgen, the third litigation existing between the parties relating to Amgen’s Mvasti® (biosimilar bevacizumab). The 25 patents at issue in this suit are the 24 patents included in the first Genent...

Amgen withdraws EU application for Kyomarc® (biosimilar bevacizumab), for “marketing reasons”, but will continue with existing application for Mvasti®.  Read more