FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.
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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
By Bioblast Editor | May 01, 2017
Plaintiffs Sanofi and Regeneron filed a notice of voluntary dismissal, discontinuing without prejudice the proceedings they commenced in the District Court of Massachusetts in March 2017 in which they were seeking a declaration of non-infringement in relation to Amgen’s Dup...
By Bioblast Editor | Apr 25, 2017
Glenmark announces FDA approval for Phase I clinical trials of omalizumab.
By Bioblast Editor | Apr 24, 2017
FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.
By Bioblast Editor | Apr 04, 2017
Sandoz receives a Notice of Compliance for Erelzi® for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis. (Sandoz did not seek registration for pso...
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