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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.

Sandoz announces it has received EU approval for Zessly® (inflliximab) for all originator indications.

The FDA approved Hospira’s Retacrit®, biosimilar to Amgen’s Epogen® (epoetin alfa-epbx), to treat anaemia and to reduce allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Catalent announced a collaboration for the development and manufacture of Valerius’ biosimilar products.   Catalent will provide cell line development and support cGMP manufacturing activities from Phase 1 through to commercial stages from the USA.