STAT

SEPTEMBER 6, 2023

Congress previously drew this dubious distinction in 2010, when the biosimilar pathway it set up via the Biologics Price Competition and Innovation Act (BPCIA) conferred 12 years of data exclusivity on originator biologics, seven more than is given to originator small molecules under the Hatch-Waxman Act.

Biosimilars 335

Biosimilars Drug Pricing 335

Integra X Files

APRIL 3, 2023

Drugs vs. Biologics: What’s the Difference If you ask a layperson about biosimilars, you are likely to hear comparisons to generic drugs, and that would not be completely wrong. Biosimilar products are not drugs and they are not generic, in the sense that they’re not identical to the reference product.

Biosimilars 78

Biosimilars Drug Pricing 78

FDA Law Blog: Biosimilars

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. NDA or BLA drugs). Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

Dosage 59

Dosage Drug Pricing Pharmaceutical Manufacturing 59

pharmaphorum

SEPTEMBER 8, 2020

In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. In the US, biologic medicines represent 2% of medicine budget volume yet represent 37% of net drug spending. 7 Delivering on the Potential of Biosimilar Medicines.

Biosimilars 99

Biosimilars Drug Pricing Chemotherapy Vaccines 99

Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.

Drug Pricing 150

Drug Pricing Biosimilars Vaccines Drug Development 150