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Biocon’s Malaysia Insulin Plant Wins EU Clearance, Company Is Open To PE Investment

 
• By Penelope MacRae

Biocon has received European regulatory clearance for its new Malaysian insulin plant and also said it is open to private-equity investment proposals for its fast-growing biologics division ahead of a planned IPO.

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Biocon has good European clearance for its insulins facility in Malaysia • Source: Shutterstock

Biocon’s new Malaysian plant, where the Indian biotech heavyweight is making its insulin biosimilar that is a challenger to Sanofi’s blockbuster Lantus, has cleared a key regulatory hurdle. The facility, Asia’s largest integrated insulins plant, has received a certificate of good manufacturing practice from European regulators that Biocon said will help the company supply the EU diabetes market “even more aggressively.”

Biocon founder and chief executive Kiran Mazumdar-Shaw also said she is open to private-equity investment ahead of the firm’s planned spinoff of its biological arm, Biocon Biologics, that is believed to be still several years away. “As a need to grow this business, we’re always looking at investments prior to our publicly stated plan to take the company public. So, from that point of view, we’d be looking at some pre-listing investment,” she told India’s CNBC-TV18

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Generics Bulletin, or if you love it how it is, now is the time to have your voice heard.

Is Towa’s Guidance For 2024 ‘Somewhat Mediocre?’

 
• By Dean Rudge

Bringing in sales that translated to nearly $1.5bn last year, Japan’s Towa was feeling upbeat after a challenging few years, both for itself and the broader Japanese generics market. However, its financial guide for the next 12 months has left investors feeling cold.

Publisher’s Spotlight: Citeline News And Insights App

 
• By Generics Bulletin Team

Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.

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Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.