Next year, the UK will conclude its transition from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK’s Medicines and Healthcare ...
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By Naomi Pearce | Oct 19, 2020
Next year, the UK will conclude its transition from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK’s Medicines and Healthcare ...
By Bioblast Editor | Oct 16, 2020
Polpharma publishes ustekinumab biosimilar is under development.
By Bioblast Editor | Oct 16, 2020
Janssen announced that the CHMP has adopted a positive opinion recommending the expanded use of Tremfya® (guselkumab) to include the treatment of adult patients with active psoriatic arthritis.
By Bioblast Editor | Oct 15, 2020
Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the regulatory approval process for that product.
By Bioblast Editor | Oct 15, 2020
Henlius and Essex announce they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally. Essex wi...
By Bioblast Editor | Oct 13, 2020
Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Governm...
By Bioblast Editor | Oct 13, 2020
The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma’s proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was...
By Naomi Pearce | Oct 12, 2020
Significant biosimilar activities this week include
05 Oct 20 | Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the reg...
By Bioblast Editor | Oct 12, 2020
Two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, ar...
By Bioblast Editor | Oct 10, 2020
Celltrion presents positive interim results from Ph I trials of CT-P13 of subcutaneous Remsima® (biosimilar infliximab) in IBD at the UEG Week Virtual 2020. The results indicated that subcutaneous infliximab may be associated with better clinical outcomes compared to intrav...
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