FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. The Court thus explained that interpreting the patent in 35 U.S.C.

Drug Pricing 59

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

STAT

OCTOBER 18, 2024

Or you could hide indoors with a good book. drug prices and repeal the Affordable Care Act, leaving something of a vacuum in his health policy agenda. One drug prices to a basket of payments made by similarly wealthy countries, but has retreated from that approach. Well, whatever you do, have a grand time.

Drug Pricing 259

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 259