Pearce IP BioBlast: w/e 17 July 2020
Significant biosimilar activities this week include:
09 Jul 20, AU: 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.
Remsima® (biosimilar infliximab) was showing promise as a potential treatment for COVID-19.
Celltrion plans to launch one biosimilar a year until 2030.
Celltrion applied for EU marketing approval for high concentration ("citrate free") CT-P17 (proposed biosimilar adalimumab) in March 2020, and Celltrion has plans to file in the US.
Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year.
Phase I and III trials of Celltrion's omalizumab candidate are ongoing, and are expected to conclude by 2022.
14 Jul 20, US: 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 implementation of new policies which may help increase biosimilar uptake when clinically appropriate.
17 Jul 20: Bio-Thera Solutions annnounced a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.
17 Jul 20: VentureTECH, Duopharma and PanGen Biotech announced a joint venture to develop a Malaysian biosimilar production facility.