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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.

FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

Australia’s NeuClone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

Coherus provides 2018 forecasts in its Q1/2018 results, including EU approval opinion by 28 June 2018, and US BLA acceptance by 3 June 2018. Commercial discussions ongoing.