Biosimilars major Celltrion has announced further progress on its biosimilar Xolair candidate, as it faces off against the likes of Glenmark to introduce global competition to Genentech/Novartis’ blockbuster cardiovascular biologic.
Celltrion is making further strides on one of the significant ‘next wave’ biosimilar opportunities, kicking off a global Phase III trial for biosimilar Xolair (omalizumab) following approval for the firm’s investigational new drug application from Korea’s Ministry of Food and Drug Safety.
Phase III trials for the Korean firm’s CT-P39 biosimilar omalizumab candidate are scheduled to be conducted “through about 65 clinical trials in seven countries around the world, including in Korea,
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.
Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.
Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.
Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.
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.
