Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines
Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.
Share
Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024). 1 However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade.
The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines:
Health Technology Assessment (HTA) needs to be tailored for biosimilars: With its origin in innovative medicine, HTA is a multidisciplinary process that evaluates the medical, social, economic, and ethical implications of health technologies. Some countries often have oversimplified HTA requirements for biosimilars, where reimbursement decisions are solely based on price comparisons and do not take into account biosimilars' additional benefits or where the reference biologic is not reimbursed. In many cases, HTA is relevant, but with limited guidance to properly assess the biosimilar's value. HTA can be more streamlined and tailored to speed up the entry of biosimilars to the market.
In some countries, pricing and reimbursement (P&R) policies focus on achieving the lowest possible prices through mechanisms such as price linkage and reference pricing, thereby accelerating price erosion: Out of 28 European countries, 12 countries use external reference pricing methods and 17 countries mandate arbitrary discounts on biosimilar prices at an average of 28% below reference product. 2 Already set at significantly lower levels, biosimilar prices are driven further downward as competition begins, often leading to price erosion that drives players out of the market. Instead of arbitrary price-controls, free pricing will allow price discounts to be achieved naturally through free competition.
Tenders often favor a single-winner system and tend to overlook broader qualitative factors such as supply stability and quality assurance: National, regional, and local tenders should support supply diversification and fair competition through multi-winner systems, with greater transparency in communication and more periodic tender reopenings so that late entrants are also given opportunities to participate. Security and stability of supply should be given higher priority in tenders to enhance demand predictability and incentivize manufacturers to secure more robust supply chains.
Biosimilar uptake cannot be achieved without the support of physicians and pharmacists who prescribe and dispense these medicines: Incentives extended to healthcare professionals to encourage the prescribing and dispensing of biosimilars vary significantly across European countries. In some countries, prescriber incentives are misaligned, discouraging the use of biosimilar medicines. Incentive programs should be based on shared decision-making between physicians and patients, rather than automatic switching. Gainsharing can be introduced to stimulate biosimilar uptake while preserving competition and autonomy. Education programs for physicians, pharmacists, and patients should be continued to support wider use of biosimilars.
'Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,' said Adam Levysohn, Vice President and Head of Commercial Strategy Europe, at Samsung Bioepis. 'It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.'
Samsung Bioepis is a biopharmaceutical company that develops and manufactures high-quality biosimilars to accelerate patient access to biologic medicines. As a world leader in biosimilars, Samsung Bioepis has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Of the 11 biosimilars approved worldwide, eight products are available across Europe.
To access the report Solving the Biosimilar Void in Europe, please visit HERE.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
Biocytogen Upgrades Preclinical Service Platform and Launches Revamped Global Website
BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced a comprehensive upgrade to its preclinical business division. The upgrade features an expanded portfolio of genetically engineered animal models—including target-humanized, immune-humanized, transgenic, and immunodeficient mice—alongside a full suite of preclinical services such as efficacy studies, PK/PD analysis, biomarker evaluation, and non-GLP toxicology testing. In parallel, the company also launched its new official website ( featuring an intuitive structure, enriched content, and an optimized multilingual user experience to serve global clients and partners better. Extensive Model Portfolio with Over 1,100 Target-Humanized Mouse Models In 2021, Biocytogen launched the 'BioMice' sub-brand to advance its portfolio of genetically engineered mouse models. Leveraging its proprietary gene-editing platform, the company has developed more than 1,100 target-humanized mice. These models are generated using precise in situ gene replacement technology, which substitutes mouse genes with human sequences while preserving endogenous gene regulation. This approach enables a more accurate simulation of human physiological and pathological conditions, establishing BioMice as the gold-standard platform for evaluating the efficacy and safety of various therapeutic modalities, including antibody drugs, cell therapies, bispecific/multispecific antibodies, ADCs, and oligonucleotide-based treatments. The company has established high-value disease models for oncology, autoimmune, metabolic, and neurological disorders, including CD3 (TCEs), HER2 (TAAs), TL1A (IBD), TSLP (AD), GLP1R (muscle gain/weight loss), and TFR1 (BBB delivery). These models are widely used for target validation, mechanistic studies, and preclinical evaluations. To date, safety data generated from these models have supported 15 IND approvals by China's NMPA and 5 IND approvals by the U.S. FDA (including 4 dual submissions). Biocytogen also offers immune-humanized mouse models (e.g., huPBMC-B-NDG, huHSC-B-NDG, huHSC-B-NDG hIL15, and huPBMC-B-NDG MHC I/II DKO plus), transgenic mice, and immunodeficient strains to support evaluations of immuno-oncology agents, T/NK cell therapies, and immunostimulatory drugs, building a comprehensive and multi-dimensional model portfolio. Global Animal Supply Network Supporting Efficient Preclinical Research Biocytogen operates three AAALAC-accredited animal facilities in Haimen (Jiangsu), Daxing (Beijing), and Boston (USA), covering a total area of 55,000 m² and offering an annual supply capacity of over 800,000 laboratory animals. With a robust quality control system and standardized microbial monitoring, Biocytogen has established an international distribution network spanning Asia, Europe, and North America. The company's mouse models have been successfully delivered to clients in over 20 countries and regions, providing reliable model support for global drug development efforts. Integrated Preclinical Services to Accelerate IND Filing and Clinical Translation Leveraging its proprietary animal models, Biocytogen provides one-stop, non-GLP preclinical products and services, including in vivo efficacy testing, PK/PD analysis, biomarker assessment, and early toxicology studies. With a vast collection of CDX and PDX tumor models and customizable study designs, Biocytogen serves over 20 therapeutic areas—including solid tumors, hematologic malignancies, autoimmune diseases, metabolic disorders, and neurodegenerative diseases—and supports a variety of drug modalities such as antibodies, small molecules, ADCs, bispecifics, cell therapies, nucleic acids, and vaccines. As of now, Biocytogen has completed more than 5,300 drug evaluation studies for nearly 900 pharmaceutical and academic institutions worldwide. Over One Million Fully Human Antibodies Empowering Antibody Drug Discovery Beyond preclinical services, Biocytogen also leads in antibody discovery through its proprietary RenMice ® platforms—including RenMab™ (fully human antibody), RenLite ® (common light chain), RenNano ® (VHH antibody), RenTCR™ (fully human TCR), and RenTCR-mimic™ (fully human TCR-mimic antibody). The company has built a library of over one million fully human antibody sequences against more than 1,000 potential therapeutic targets, with diverse structures and functional profiles. As of December 31, 2024, Biocytogen has signed approximately 200 drug co-development, licensing, or transfer agreements, including over 50 target-based RenMice ® platform collaborations with multinational pharmaceutical companies. Multiple clinical-stage antibody candidates have also been successfully out-licensed to global partners. Biocytogen's integrated capabilities in antibody discovery, screening, and engineering are accelerating the transition from target validation to clinical candidate selection, empowering global biopharmaceutical innovation. New Official Website Launched to Serve Global Clients To enhance global service capabilities, Biocytogen has officially launched its new website: Designed for a clean and intuitive user experience, the new site features streamlined architecture, upgraded content organization, improved search functionality, and multilingual support in Chinese, English, Japanese, and Korean. Structured around its two main business divisions—BioMice ® for preclinical products and services and RenBiologics™ for antibody discovery and collaboration—the site offers a comprehensive overview of Biocytogen's model products, antibody assets, project portfolios, and service capabilities. It provides an efficient and direct information portal for global partners and supports the company's ongoing internationalization strategy. About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice ® (RenMab™/ RenLite ® / RenNano ® / RenTCR-mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice ® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit
Business Wire
3 hours ago
- Business Wire
Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal® in Saudi Arabia
PARIS--(BUSINESS WIRE)--Regulatory News: Advicenne (Euronext Growth® - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, obtains marketing authorization (MA) and reimbursement status for Sibnayal® (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA). Marketing authorization for Sibnayal® (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing. This achievment results of a close collaboration between Advicenne and its local partner, Taïba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taïba Healthcare will manage local marketing activities. The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal® is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed. Didier Laurens, CEO of Advicenne, declared: 'I am particularly proud of this important achievement and wish to congratulate both Advicenne and Taïba Healthcare teams, whose efforts were instrumental in informing and convincing the Saudi health authorities. The reimbursement obtained, comparable to the highest levels recorded in Europe, further attests to the significant therapeutic value of Sibnayal® in a region with one of the highest prevalence rates of dRTA worldwide.' About Advicenne Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information, see: Disclaimer This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2024 Universal Registration Document filed with the French financial market authority on April 29, 2025 (a copy of which is available on and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
Business Wire
3 hours ago
- Business Wire
Azafaros Announces Initiation of two Global Phase 3 studies with Nizubaglustat in Niemann-Pick disease Type C (NPC) and GM1/GM2 gangliosidoses, respectively
LEIDEN, Netherlands--(BUSINESS WIRE)-- Azafaros, a company focused on developing treatments for the unmet needs of patients with rare lysosomal storage disorders, today announced that the first patient has been dosed in the company's pivotal, multicenter Phase 3 clinical program to evaluate the safety and efficacy of the company's lead asset, nizubaglustat, in patients with Niemann-Pick disease Type C (NPC) and GM1/GM2 gangliosidoses. 'The dosing of the first patient in our Phase 3 program with nizubaglustat is a significant achievement for Azafaros, and a huge step forward in our efforts to bring new, disease modifying treatments to patients with these seriously debilitating diseases,' Share The initiation of the two Phase 3 studies (NCT07054515) represents a major milestone in Azafaros' commitment to addressing the urgent unmet medical needs of children affected by these devastating neurodegenerative disorders. The Phase 3 program consists of two studies targeting the late-infantile and juvenile-onset forms of NPC, and GM1/GM2 gangliosidoses. The studies aim to assess the potential of nizubaglustat to alter disease progression and improve functional outcomes in these patient populations. Today's news follows the recent, successful completion of an oversubscribed series B financing, raising €132M to support the acceleration of nizubaglustat and the expansion of the company's pipeline to other indications. 'The dosing of the first patient in our Phase 3 program with nizubaglustat is a significant achievement for Azafaros and a huge step forward in our efforts to bring new, disease modifying treatments to patients with these seriously debilitating diseases,' said Stefano Portolano, Chief Executive Officer at Azafaros. 'We are deeply grateful to the patients, families, clinicians, and advocacy groups who are partnering with us to advance this promising therapy.' About the NAVIGATE trial The two 18-month randomized 2 to 1, double-blind, placebo-controlled trials will recruit patients at approximately 35 sites across 15 countries worldwide, including in the US, Europe and Latin America. The studies are expected to enroll around 70 patients. The primary endpoint for both trials is the change from baseline to Month 18 in the Scale for the Assessment and Rating of Ataxia (SARA), with both total and functional SARA scores evaluated. For more information on the Phase 3 program, please visit To enquire about trial participation, email: medinfo@ (if a professional) or patientadvocacy@ (if a patient or caregiver). To protect privacy, avoid including identifying information in the initial message. About nizubaglustat Nizubaglustat is a small molecule, orally available and brain penetrant azasugar with a unique dual mode of action, developed as a potential treatment for rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick disease type C (NPC). Nizubaglustat has received Rare Pediatric Disease Designations (RPDD) for the treatment of GM1 and GM2 gangliosidoses and NPC, Orphan Drug Designations (ODD) for GM1 and GM2 gangliosidosis (Sandhoff and Tay-Sachs Diseases) and NPC, as well as Fast Track Designation and IND clearance for GM1/GM2 gangliosidoses and NPC from the US Food and Drug Administration (FDA). Additionally, nizubaglustat has been awarded Orphan Medicinal Product Designation (OMPD) for the treatment of GM1 and GM2 gangliosidoses by the European Medicines Agency (EMA) and Innovation Passport for the treatment of GM1 and GM2 gangliosidoses from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). About GM1 and GM2 gangliosidoses GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) are lysosomal storage disorders caused by the accumulation of GM1 or GM2 gangliosides respectively, in the central nervous system (CNS). This results in progressive and severe neurological impairment and premature death. These diseases mostly affect infants and children, and no disease-modifying treatments are currently available. About Niemann-Pick disease Type C (NPC) Niemann-Pick disease Type C is a progressive, life-limiting, neurological, lysosomal storage disorder, caused by mutations in the NPC1 or NPC2 gene and aberrant endosomal-lysosomal trafficking, leading to the accumulation of various lipids, including gangliosides in the CNS. The onset of disease can happen throughout the lifespan of an affected individual, from prenatal life through adulthood. About Azafaros Azafaros is a clinical-stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms using compound discoveries made by scientists at Leiden University and Amsterdam UMC and is led by a team of highly experienced industry experts. Azafaros aims to build a pipeline of disease-modifying therapeutics to offer new treatment options to patients and their families. By applying its knowledge, network and courage, the Azafaros team challenges traditional development pathways to rapidly bring new drugs to the rare disease patients who need them. Azafaros is supported by leading healthcare investors including Forbion, Jeito Capital, Seroba, Pictet Group, BioGeneration Ventures (BGV), BioMedPartners, Asahi Kasei Pharma Ventures, and Schroders Capital.
