Prestige says a meeting with the FDA in November represents a “final step” before filing its trastuzumab biosimilar with the US agency by the end of the year. Meanwhile, a major shareholder has invested further in the Singapore-based biosimilars developer.
Prestige Biopharma says a meeting with the FDA in November represents a “final step” before filing its HD201 trastuzumab rival to Herceptin, also known as Tuznue, with the US agency by the end of the year.
Noting that the pre-submission biosimilar biological product development type 4 meeting would “discuss the format and content of a biologics license application in advance of the final submission,” the Singapore-based biosimilars developer said it would “discuss the
Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.
With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.
Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
