FDA approves Amgen’s biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen’s application was filed.
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By Bioblast Editor | Sep 23, 2016
FDA approves Amgen’s biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen’s application was filed.
By Bioblast Editor | Sep 12, 2016
Brenzys®(SB4) is the first biosimilar etanercept to be approved in Canada.
By Bioblast Editor | Aug 08, 2016
Pfizer terminates its relationship with Pfenex to develop PF582, biosimilar ranibizumab.
By Bioblast Editor | Jul 22, 2016
Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia.
By Bioblast Editor | Jul 21, 2016
EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review.
By Bioblast Editor | Jul 20, 2016
FDA rejects Sandoz’s application for Zioxtenzo®, biosimilar pegfilgrastim.
By Bioblast Editor | Jul 19, 2016
Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”
By Bioblast Editor | Jul 18, 2016
Samsung announces the EMA has accepted for its review its application for adalimumab biosimilar.
By Bioblast Editor | Jul 13, 2016
FDA approves Sandoz’s Erelzi® for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
By Bioblast Editor | Jun 13, 2016
Amgen announces FDA Advisory Committee Meeting to review ABP 501 (biosimilar adalimumab). FDA has set a Biosimilar User Fee target action date of 25 September 2016.
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