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Manufacturing

Set Alert for Manufacturing

Kabi: US Pegfilgrastim Crowd Is An Opportunity For Us, Not A Deterrent

In the second part of Generics Bulletin’s exclusive interview with Fresenius Kabi’s senior vice president for biosimilars in the US, Ali Ahmed, he explains why Kabi is relishing the prospect of competing in pegfilgrastim and what the acquisition of mAbxience means for the company’s prospects and vision.

Biosimilars Manufacturing

Dr Reddy’s CEO Sees Strength Through Diversity

With Dr Reddy’s organization now spanning a range of innovative interests and CDMO activities as well as the firm’s traditional small-molecule generics and burgeoning biosimilars businesses, CEO Erez Israeli talked to Generics Bulletin about how these various areas were complementary thanks to the Indian giant’s ‘two-horizon’ approach.

Strategy Generic Drugs

Fresenius Kabi: Adalimumab Customers Want Supply Guarantee, We Can Provide That

Following Fresenius Kabi’s approval in mid-December for the eighth and latest biosimilar Humira (adalimumab) product, the company’s senior vice president for biosimilars in the US spoke to Generics Bulletin about how it can stand out from the pack and why it is confident that it can succeed.

Biosimilars Manufacturing

Alvotech Lines Up FDA Inspection Ahead Of Adalimumab Action

Alvotech has secured a US FDA reinspection of its Reykjavik plant in March, ahead of the agency’s April goal date for action on the firm’s pending application for a high-concentration, interchangeable adalimumab biosimilar rival to Humira.

Biosimilars Manufacturing

FDA Promises Interchangeability For Alvotech’s 100mg/ml Humira Rival – If It Passes Inspection

Alvotech has been bolstered by a US FDA confirmation that its AVT02 adalimumab candidate can be approved as an interchangeable biosimilar based on the data provided in its filing – but first, the Icelandic firm must pass an upcoming facility inspection.

Biosimilars Approvals

Industry Breathes Sigh Of Relief Over UK Batch Release Move

One of the key regulatory conundrums thrown up by Brexit has been addressed after the government decided to continue using a list of approved countries to waive drug import testing requirements.

Europe United Kingdom

Sun Grapples With Impact Of Halol FDA Import Alert

Sun Pharma’s Halol facility has been placed under an import alert by the FDA following an inspection earlier this year that uncovered GMP deficiencies.

Manufacturing Compliance

To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Supply Chain Regulation

Stada Begins Work On Romanian Hub

Stada has begun work on a facility in Romania into which the German giant is investing more than €50m to bolster the European supply chain.

Manufacturing Strategy
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