FDA Law Blog: Biosimilars

JULY 29, 2024

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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Biosimilars Dosage Documentation 64

Pharma in Brief

SEPTEMBER 8, 2022

This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. JAMP filed a new drug submission ( NDS ) for its biosimilar adalimumab product, SIMLANDI, in three presentations: (i) a 40 mg/0.4 Guidance Document : Information and Submission Requirements for Biosimilar Biologic Drugs.

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Biosimilars Dosage Documentation 52

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

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. For example: Reduced stay. Revised section 8 damages.

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Biosimilars Dosage Documentation 52

Pharma in Brief

JUNE 21, 2020

those sold before January 1, 2021, into three categories: Grandfathered (DIN before August 21, 2019), Line Extension (DIN on or after August 21, 2021 for new dosage form/strength of Grandfathered medicine), and Gap (DIN on or after August 21, 2019 and first sale before January 1, 2021). The PMPRB has now produced revised Draft Guidelines.

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Biosimilars Generic Medicine Dosage Documentation 40

FDA Law Blog: Biosimilars

JUNE 16, 2023

After a manufacturer submits (or fails to submit) the required drug cost statement, the AG may petition a court to issue an order to, inter alia : compel the manufacturer to provide the required drug cost statement or additional information, including by answering interrogatories, producing documents, or being examined under oath; restrain or enjoin (..)

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

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Controlled Substances Documentation Dosage Prescription Filling 139