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. Evolution of the Regulations Coming into force (1993–1997).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

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.

Clinical Development 52

Clinical Development Medicine Development Containment 52

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. Disclaimer.

Clinical Development 40

Clinical Development Medicine Development Production 40

The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Source link: [link].

Medicine 52

Medicine Generic Pharmaceutical FDA Approval Packaging 52

The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. Source link: [link]

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

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.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

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.

Sales 40

Sales Production Doctors Doctor 40