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Biocon-Mylan Prime Pegfilgrastim Market Expansion

US Approves Biocon’s sBLA for New Pegfilgrastim Facility

 
• By Anju Ghangurde

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.

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Biocon-Mylan Build Additional Capacity For Fulphila • Source: Shutterstock

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.

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Transient FY26 For Syngene But Momentum In China +1 Projects

 
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As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

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US Tariffs And Manufacturing Concentration: Double-Edged Sword?

 
• By Anju Ghangurde

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More from Focus On Asia

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
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Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
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Novotech CEO On Flexible Trial Solutions Amid Tariff, Geopolitical Tensions

 
• By Anju Ghangurde

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.