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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.

Samsung is approved by the Ministry of Food and Drug Safety in South Korea to commence Phase III clinical trials for biosimilar ranibizumab.

Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer.  This is the first biosimilar trastuzumab recommended for EU approval.

BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab.  Approval is expected in Q4/17.

Amgen/Allergan’s bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer.  Read more