Tagged with BI

Germany The latest news from German pharma, including looming drug pricing reform, Boehringer Ingelheim’s EUR 640 million acquisition of a Kyowa Kirin autoimmune drug, and BioNTech’s updated revenue guidance. Also covered are Merck KGaA’s tie-up with JSR Life Sciences for its chromatography business, Bayer’s 12,000 layoffs, and STADA’s potential IPO.  …

Taiwan After more than two decades in Silicon Valley, Dr Jeng Her returned to Taiwan with a bold ambition: to help transform its emerging biotech sector into a globally recognised force in antibody innovation. As Founder and CEO of AP Biosciences, he has positioned the company at the forefront of bispecific…

Taiwan Dr Wen-Liang Huang, General Manager of Ever Supreme Biotechnology, brings over 40 years of clinical cardiology experience to biopharmaceutical leadership. Recruited by the company’s founder, his medical background informs the translation of cell therapy innovations into meaningful patient treatments. Under his guidance, Ever Supreme has become Taiwan’s pioneering cell therapy…

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 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…

Pharma Legal Handbook Which are the main actors involved in public procurement and tendering? In Saudi Arabia, the main actors in the public procurement and tendering process for pharmaceuticals include: NUPCO (National Unified Procurement Company): Acts as the central purchasing agent for the Ministry of Health (MOH), Ministry of Defense, National Guard, and…