Generic Pharmaceutical Medicine Regulation 
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.
The Pharma Data
MAY 8, 2021
The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. Our ambition is to be the world’s leading and most valued generics company.
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The Pharma Data
MAY 2, 2021
With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. billion.
Pharma in Brief
SEPTEMBER 19, 2023
Background All three decisions arose during proceedings commenced pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court concluded that there was no basis for such an Order in the Rules , the Regulations , or the jurisprudence.
The Pharma Data
MAY 18, 2021
By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. billion.
The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. Today, the U.S. Source link: [link] ov/.
The Pharma Data
MAY 15, 2023
Shamiram holds an AB from Smith College and Doctor of Medicine as well as a Master of Public Health, both from Emory University, U.S.A. About Novartis Novartis is reimagining medicine to improve and extend people’s lives. Our ambition is to be the world’s leading and most valued generics company. billion.
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