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Celltrion reports preliminary results for new sub-cut formulation of infliximab.

Walgreen and Kroger also file suit against J&J in the Pennsylvania District Court, echoing Pfizer’s earlier (Nov 17) complaint alleging J&J has engaged in anti-competitive behaviour regarding the US sale of Remicade®.

FDA approves Mylan/Biocon’s pegfilgrastim (Fulphila®) on Mylan’s resubmitted application.  This is a the first US Neulasta® biosimilar approved; the second US biosimilar approved from the Mylan/Biocon portfolio; and the tenth US biosimilar overall.  See related ...

Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.

FDA provides CRL rejecting Amgen’s application for biosimilar trastuzumab ABP 980, filed August 2017.  Amgen states “we do not expect this to impact our US launch plans.”

CHMP recommends granting a marketing authorisation to Pfizer for its biosimilar trastuzumab (Trazimera®) for the treatment of breast and gastric cancer.

CHMP recommends granting marketing authorisation for 3 biosimilar AmAbs developed by Sandoz – Halimatoz, Hefiya and Hyrimoz.

Celltrion resubmits its aBLA for CT-P10 (rituximab) biosimilar Rituxan®.  According to Celltrion, the FDA has resumed the approval procedure and Celltrion expects approval in 2018.

Celltrion announces that it intends to refile its aBLA for CT-P6 (trastuzumab) in June 2018 with a view to obtaining approval in 2018.

Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA.