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

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Court also found that two other patents, which cover dosage regimens and new uses of adalimumab, are invalid for obviousness.

Biosimilars 52

Biosimilars Dosage 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. It acts as a mobilization agent and should be injected subcutaneously with dosage depending on body weight. As of now, there are no the US FDA approved biosimilars available for Actemra.

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Biosimilars Diabetes Chemotherapy Immunity 49

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

As those of us of a certain age remember, prior to 2005/2006, pseudoephedrine was the decongestant of choice for OTC multi-symptom cold medicine. As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website.

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Pharmacy Management Dosage Documentation 111