Biocon-Mylan’s sBLA approval for pegfilgrastim made at a new Indian site gets FDA go-ahead, facilitating a "multi-fold" scale up in capacity. But it will be interesting to watch how impactful this could be on market dynamics in the US, where more competition has arrived.
Biocon Ltd. and partner Mylan NV expect expanded manufacturing capacity for pegfilgrastim to address growing market opportunities in the US for Fulphila (pegfilgrastim-jmdb), their biosimilar rival to Amgen Inc.’s Neulasta reference biologic, amid the imminent entry of more competition.
The add-on capacity will come after the US Food and Drug Administration approved Biocon and Mylan’s supplemental Biologics License Application...
Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.
Indegene’s CTO talks to Scrip about the state of GenAI implementations in pharma amid hype and limited clarity on ROI, the need to address foundational issues early on, promising pilots, the firm’s alliance with Microsoft and Google’s generalist LLM for therapeutics.
Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.
Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
