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Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.

MSD’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.

Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.

Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).

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.