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How Star Wars Explains Biosimilar Labeling Problems

 
• By Derrick Gingery

US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.

Star Wars trash compactor scene
Like the Death Star trash compactor in Star Wars, the FDA's biosimilar labeling practices squeeze sponsors from two sides, attorney Eva Temkin said. • Source: Alamy

Writing biosimilar labels may not exactly compare to being trapped in the Death Star, but attorney Eva Temkin said that part of the original Star Wars movie illustrates the conundrum sponsors face when dealing with the US Food and Drug Administration’s expectations.

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• By Derrick Gingery

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Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

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• By Urtė Fultinavičiūtė

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