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AAM Urges US Senate To Back Domestic Production

While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Manufacturing United States

Celltrion Selected For Korean-Made Insulin Biosimilar

Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.

Biosimilars Strategy

FDA Re-Evaluates Orange Book Patents

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Intellectual Property Regulation

Mylan And Lupin Prepare To Launch EU Etanercept

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

Biosimilars Approvals

Alvogen Group Unveils Adalvo B2B Unit

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Strategy Manufacturing

CJEU Opinion Backs Lundbeck Fine Over Citalopram ‘Pay For Delay’ Deals

A CJEU advocate general has backed a European Commission fine of almost €94m imposed on Lundbeck over “pay for delay” deals struck with four generics firms over citalopram.

Legal Issues Regulation
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