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Mylan Looks To Expedite Biosimilar Humira in EU Through Kyowa Deal

 
• By Anju Ghangurde and Ian Haydock

Mylan has acquired commercial rights in Europe to Kyowa Hakko Kirin's biosimilar adalimumab, paving the way to an early market entry through the product, which could be approved in the second half of this year. But might there be a shift in the commercialization outlook for its partnered adalimumab with Biocon?

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MYLAN GAINS EU RIGHTS TO BIOSIMILAR HUMIRA

Mylan NV is to jump start its plans for biosimilar adalimumab in Europe through an alliance with Japan’s Fujifilm Kyowa Kirin Biologics Co. Ltd. (FKB), in a move that may have an impact on Mylan's existing biosimilars alliance with Indian firm Biocon Ltd..

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OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

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.

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

 
• By Vibha Ravi

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

Enzene Sees Tariff Exemptions For India, Front-Ends US Capacity

 
• By Vibha Ravi

Enzene's CEO Himanshu Gadgil anticipates exemptions for Indian products from US tariffs expected to be imposed on pharmaceuticals. In an interview ahead of the US Vice Premier's India visit, he also talks about front-loading capacity at Enzene's US plant and a change in its biosimilars strategy

More from Focus On Asia

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

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

 
• By Vibha Ravi

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

 
• By Dexter Jie Yan

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.