Read our latest updates & insights

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...

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...

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...

Innovent and Eli Lilly jointly announce China’s NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffuse large b cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.

Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).

In its annual 2020 budget, the Australian Government acknowledged the damage to Australia’s economy caused by vaccine uncertainty.  The Government also pledged $23.2 million over the next three years to the COVID-19 Vaccine Access and Health Security Program to suppor...

Significant biosimilar activities this week include
28 Sep 20 | Innovent announced its Ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival.  Inno...

Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).

Onco’Zine reports a new study released by the American Society of Clinical Oncology Quality Care Symposium indicates that Sandoz’s Zarxio® (biosimilar filgrastim) is not only safe and effective, but is cost effective in treating chemotherapy-induced febrile neut...

Medicure announces 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.