Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. However, 505(b)(2) drugs have been available since the 1980s. “CMS

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Dosage Hospitals 26

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

Communication 105

Communication Dosage Biosimilars 105

FDA Law Blog: Biosimilars

MARCH 12, 2024

Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form.

Dosage 45

Dosage 45

PharmaShots

JUNE 28, 2023

Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. Clinicaltrial.gov 4.

Biosimilars 40

Biosimilars Insurance Coverage and Processing Dosage Compounding 40