Tagged with EG

LatAm Vaccination remains the most powerful public health intervention ever devised, preventing an estimated 4.4 million deaths each year, according to the WHO. Yet with misinformation spreading faster than science, and routine immunisation disrupted by pandemic aftershocks, even long-protected regions are witnessing a resurgence in preventable diseases. In Latin America, where…

France At the helm of EG Labo (STADA Group), Tiago Bartolomeu is steering one of France’s leading accessible medicine players through a period of renewal and ambition. With a clear focus on expanding access through generics, biosimilars, and consumer health, he reflects on the company’s growth strategy, its role as a…

USA Norman Stoffregen, SVP and Site Head at Enzene Inc., explains how the US arm of India’s Enzene Biosciences is introducing its cost-efficient, continuous manufacturing model to the US CDMO market. With a state-of-the-art facility in Hopewell, New Jersey, Enzene supports mid-sized biopharma clients with flexible, small-footprint biologics production. By combining…

USA Thomas Nusbickel, Chief Commercial Officer, describes how Celltrion, founded over 20 years ago, pioneered biosimilars through a fully integrated business model. Its US office opened in 2018 and has since transitioned from partnerships to direct sales, launching several biosimilars in oncology, immunology and endocrinology. With a strong pipeline, a growing…

Taiwan Dr Chiu-Heng Chen (John), CEO of LaunXP, brings a unique perspective to oncology drug development shaped by his personal experience with cancer during his PhD in the UK. Holding advanced degrees from British and Taiwanese institutions in tumour oncology, he founded LaunXP in 2015 to bridge academia and clinical practice,…

Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization Saudi Arabia provides universal health coverage primarily funded by the government through a tax-based model. The healthcare system is organized in a tiered structure led by the Ministry of Health (MOH), which operates: •…

Pharma Legal Handbook Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private),…

Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket…

Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in…

Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. The SFDA published the Economic Evaluation Studies Guideline (PDF, July 10, 2024), which outlines comprehensive methods and includes a checklist. Followed by the Pharmacoeconomic Submission Portal Manual (January 2025), detailing dossier preparation and submission protocols.…

Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for   a. Market approval In addition to clinical trial data, the following documents are required for market authorization in Saudi Arabia: Quality/CMC Module: Includes full GMP certificates (PIC/S or WHO type) and a local…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, Saudi Arabia has implemented two types of Managed Entry Agreements (MEAs) under the Ministry of Health’s “Managed-Entry Agreement Policy” issued in January 2021. These include: A. Finance-based Price/Volume Agreement 1. Fundamentals & rationale…