Drug Channels

APRIL 29, 2024

April is over, so it's time to hop into this month’s selection of noteworthy news: CVS Health’s formulary boosts a Humira biosimilar An insurer ditches buy-and-bill to save money for plans—but maybe not for patients? Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

Specialty Pharmacies 79

Specialty Pharmacies Biosimilars 79

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

Biosimilars 130

Biosimilars Drug Pricing 130

Big Molecule Watch

NOVEMBER 6, 2023

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. For drugs selected for the first year of the Program, negotiations will end by August 1, 2024.

Drug Pricing 67

Drug Pricing Biosimilars 67

Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Documentation 119

Documentation 119

FDA Law Blog: Biosimilars

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. This will apply to all meeting requests received on January 22, 2024, or later. In June 2023, the list expanded to include Type B End-of-Phase 2 meetings (which we blogged about here ).

Biosimilars 59

Biosimilars Drug Development 59

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Pursuant to FSMA, FDA amended the requirements for prior notice of imported food, to include a requirement to report the name of any country to which the article has been refused entry. The proposed rule also establishes a timeframe by which food articles subject to refusals or holds must become compliant.

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