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If approved in the US, Samsung Bioepis' adalimumab biosimilar may launch June 30, 2023, five months after the market entry date for Amjevita under Amgen's agreement with AbbVie; the 150-day marketing advantage for the first biosimilar approved suggests a benchmark for future patent litigation settlements.
USP's proposed change aimed at harmonizing with FDA's suffix-based naming system for biologics would 'aggravate existing concerns' that biologic product-specific monographs are too inflexible and may impede development of biosimilars, agency says in a letter publicized through a tweet by the commissioner.
Proteostasis planned to raise cash this week, but scrapped the offering after an investor that shorted the stock published a scathing report. Also, Arena raised more than $350m in an offering after its positive Phase II etrasimod data, and venture capital flows to biopharma firms with big ideas.
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