FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. “2021 Generic Drug & Biosimilars Access & Savings in the U.S. ” JAMA, 2016. Association for Accessible Medicines. Kesselheim, A.S.,

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FDA Law Blog: Biosimilars

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. By Larry K. codified at 21 C.F.R. b)(5)(ii)).

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Frequent amendments (1998–2016). For example: Reduced stay.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

In the most recent eight factor analyses prior to August 2023, in 2016 HHS and DEA concluded that marijuana continued to meet criteria for remaining in schedule I. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

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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.” 26 April, 2016. References. Why Patents Are the Lifeblood Of Biotech Companies.

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