Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.
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By Bioblast Editor | Mar 15, 2021
Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.
By Bioblast Editor | Mar 14, 2021
The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act.
The Ensuring Innovation Act aims to stop ‘evergreening’ by preventing pharmaceutical companies from claiming new innovations when they make insign...
By Naomi Pearce | Mar 11, 2021
Date: 11 May 2021
Forum: Australian Patent Office
Delegate: Ranganath Subbarayan
Background
Mr Arieni was a former colleague of one of the named inventors (...
By Bioblast Editor | Mar 10, 2021
Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA ...
By Naomi Pearce | Mar 08, 2021
01 Mar 2021 | EU | Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abe...
By Bioblast Editor | Mar 05, 2021
Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).
By Bioblast Editor | Mar 04, 2021
On 4 March 2021, the Australian TGA approved Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, as well as Crohn’s disease, ulcerative colitis...
By Bioblast Editor | Mar 03, 2021
The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injecti...
By Bioblast Editor | Mar 02, 2021
Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreemen...
By Bioblast Editor | Mar 01, 2021
Pharmaceutical Technology reported AbbVie’s intended Humira® follow on Rinvoq® (upadacitinib) may face questions on class safety after a safety signal emerged in a postmarketing trial of Pfizer’s Xeljanz® (tofacitinib). Tofacitinib and upadacitinib are both JAK ...
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