FDA Law Blog: Biosimilars

JUNE 13, 2024

Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. And on X (R.I.P.

Dosage 116

Dosage 116

FDA Law Blog: Biosimilars

MARCH 26, 2024

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book. Because a “drug product” is defined by regulation as a “Finished dosage form.

Dosage 59

Dosage 59

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

Communication 105

Communication Dosage Biosimilars 105

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., FDA borrowed this definition from 21 C.F.R.

Biosimilars 59

Biosimilars Dosage 59

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book.

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

FDA Law Blog: Biosimilars

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

Dosage 59

Dosage 59