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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

FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.

Amgen files suit (Central District of California) seeking DJ that 27 patents are invalid/unenforceable/not infringed by Amgen’s biosimilar bevacizumab Mvasti®. Read more.  On the same day, Genentech commenced suit in District of Delaware against Amgen relating to Mvas...

In March 2017, Sanofi and Regeneron sought inter partes review of Immunex’s patent US8679487 on the grounds of lack of novelty, relying on a single alleged prior art publication.  The PTAB denied the institution of a review, deciding that the petitioners had not established...

EMA accepts Cinfa Biotech’s application for B12019, biosimilar pegfilgrastim.

Sanofi announced that the EC has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Dupixent was approved by the FDA in March 2017.

Amgen and AbbVie settle global patent disputes regarding adalimumab, and Amgen secures a royalty-bearing, non-exclusive license to AbbVie’s Humira® IP.  Amgen’s license commences in the US on 31 Jan 2023, in most EU countries on 16 Oct 2018, and “on other ...