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In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports that Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year.

In its approval of the FY2021 Labor, Health and Human Services, Education and Related Agencies bill, the House Appropriations Committee has expressed concern over the under-utilisation of low cost biosimilars. The Committee has encouraged the CMS to support development and ...

Significant biosimilar activities this week include
05 Jul 20 | In its 2019-2020 Annual Report, Biocon announced it plans to list Biocon Biologics on Indian markets within the next two to three years, depending on market conditions.
07 Jul 20 | Outlook Therapeut...

CSL announced it has commenced Ph I trials of its proposed COVID-19 vaccine. The clinical batch of vaccine for use in the trial has been manufactured by the UQ and CSIRO, with technical assistance from CSL and Cytiva.

The Australian Generic and Biosimilar Medicines Association (GBMA) announced it reached over 540,000 Australians in its Biosimilar Awareness Week, which was held digitally May 25-29.

Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.

The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.

Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06....

Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).