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Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.

Biocon announces Biocon and Mylan add insulin glargine 300 and pertuzumab to their collaboration.

Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab.  The FDA has highlighted the need for further technical information.

Celltrion’s rituximab biosimilar Truxima® is approved by the TGA. This is the second biosimilar approved in 4 months, following the approval of Sandoz’s Riximyo™ in December 2017.

Mylan announces EU deal with Fujifilm (with other territories still under negotiation) relating to Fujifilm’s biosimilar adalimumab, filed in EMA on 18 May 2017 with approval expected “late 2018”.  Mylan’s existing partner Biocon will receive payment...

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be r...

Samsung announces a royalty-bearing, global settlement with AbbVie enabling Samsung to launch its SB5 biosimilar adalimumab in Europe from 16 October 2018 and in the US from 30 June 2023.  The EU date is the same as AbbVie gave Amgen’s in its September 2018 global set...