FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.

Compounding 105

Compounding Drug Development Drug Pricing Dosage 105

European Pharmaceutical Review

OCTOBER 19, 2022

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. Biopharmaceutical Research & Development: The Process Behind New Medicines. CN202010111235.3A.

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

Pharmaceutical Technology

SEPTEMBER 26, 2022

These highlight the parent company’s focus on innovative and high-value drug development. Novartis said in August that it intended to shut down its Sandoz oral solid dosage plant in Wilson, North Carolina, which provides tablets to Canada and the US, next year.

Biosimilars 64

Biosimilars Drug Development Vaccines Dosage 64

Drug Patent Watch

DECEMBER 18, 2024

According to a 2021 study by the Tufts Center for the Study of Drug Development, the average cost to develop a new drug is a staggering $2.6 A robust patent strategy often involves filing multiple applications at different stages of drug development. billion[1].

Drug Development 98

Drug Development Compounding Dosage Pharmaceutical Companies 98

Drug Patent Watch

DECEMBER 19, 2024

These protect the core molecule or compound that gives a drug its therapeutic effect. Formulations and Dosage Forms Patents covering specific formulations or dosage forms can extend protection beyond the API. Q: What role does patent portfolio management play in drug pricing?

Pharmaceutical Companies 92

Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 92