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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 ...

Iranian biopharmaceutical company AryoGen Pharmed commences phase III denosumab trials comparing the efficacy and safety of AryoGen’s 60mg denosumab and Amgen’s 60mg denosumab among osteoporotic post-menopausal women.

Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.