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BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.

PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab.  The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,...

Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.

Korean BIOCND shares its plans to complete the phase 1 clinical trials of Lucentis biosimilar (BCD 300) by the end of 2017 and then will seek a partner.

Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more

Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017, and receives unanimous recommendation for approval by FDA OCAC.

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.

Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more 

Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more

FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.