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Sandoz reports results of long term switching studies for biosimilars Zessly®(infliximab) and Erelzi® (etanercept) in RA.

Biocad announces phase III clinical trials of ASART-2, biosimilar infliximab, reveal non-inferiority to Remicade at week 54.

The National Institute for Health and Care Excellence (NICE) rejects pertuzumab for adjuvant treatment of early breast cancer. The draft guidance reports that the drug may not extend patient’s lives and is not cost effective.

Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA.

Fresenius reports the results of its Ph III studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism’s Annual European Congress of Rheumatology.

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.