FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.
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By Bioblast Editor | Jun 29, 2017
FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.
By Bioblast Editor | Jun 27, 2017
Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.
By Bioblast Editor | Jun 23, 2017
Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHMP in EMA.
By Bioblast Editor | Jun 19, 2017
EU approval received for Sandoz’s Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.
By Bioblast Editor | Jun 12, 2017
FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.
By Bioblast Editor | May 24, 2017
Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.
By Bioblast Editor | May 22, 2017
Fujifilm announces EC has accepted its MA for biosimilar adalimumab (FKB327) which Fujifilm filed in April 2017. Clinical trials were conducted in RA and commenced in Dec 2014.
By Bioblast Editor | May 19, 2017
Janssen commences BPCIA proceedings against Samsung Bioepis in the District Court of New Jersey based on Samsung’s aBLA application for Renflexis® infliximab-abda, biosimilar to J&J’s Remicade®.
By Bioblast Editor | May 17, 2017
Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).
By Bioblast Editor | May 11, 2017
Germany’s Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch. Read more
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