Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the filing. Development partner Stada said it would “work closely” with Xbrane and US licensee Bausch + Lomb to get the product to market.
Xbrane Biopharma has withdrawn its biologics license application for a biosimilar rival to Genentech’s Lucentis (ranibizumab) in the US after the US Food and Drug Administration said it would need more information to accept the filing.
The product, developed under the name Xlucane, is one of Xbrane’s leading biosimilar candidates. The Swedish firm has collaborated with Stada to develop the product, while Bausch + Lomb has licensed US and Canadian marketing rights
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.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
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.”
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.
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
