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Thirty years of the Patented Medicines (Notice of Compliance) Regulations

Pharma in Brief

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).

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

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. Disclaimer.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine | Novartis

The Pharma Data

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.

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Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

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].

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

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.

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New Sandoz Board of Directors appointed

The Pharma Data

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022. Gallen (HSG), Switzerland.

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