The discussion related to these products has changed dramatically from those had in previous years; in the past, the industry was discussing the regulatory framework and how the different regulatory agencies, from Mexico to Argentina, would regulate these new therapeutic options. Now, after the maturity of the laws and the construction of different regulatory pathways for biosimilars in most of the countries, the discussion has moved on to the different challenges that the industry, whether local or foreign, faces in commercializing biosimilars.
In most of the countries, governments are promoting the introduction of the biosimilars, due in part to the constraints they face in paying for high-cost innovative biologics, in addition to controlling healthcare spending linked with the increasing prevalence of diseases like cancer, diabetes, and other chronic conditions.
In the coming years, we will see a dynamic market with many players moving between countries with different regulatory frameworks and health system compositions, all trying to survive deep price reductions while demonstrating added value through the development of more real-world evidence or benefits in product improvements. At the same time, we will see these players increasing patient access to medicines. In the end, patients will benefit from these market dynamics with the introduction of therapeutic options that can help to overcome the access disparities that our region currently has.
Industry Executives from Latam
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Business Development
Maria Concepcion Prieto Yerro
CHMP committee member
Program at a Glance
RIS Amendment Update
Implementing Partnerships and Learnings from Covid-19 Vaccines Production
Round Table: Education, Awareness and their importance to Build Biosimilars Confidence among Prescribers and Patients
Patient Safety Efforts and Achievements
Upcoming Considerations for RIS Amendment Implementation
Round Table: Commercial Opportunities Surrounding Biosimilars
Forthcoming Biosimilars Research, Development and Production Considerations
Full programme in the PDF Agenda
Amgen is committed to unlocking the potential of biology for critically ill patients with the discovery, development, manufacture and launch of innovative human treatments. This approach begins with the use of tools such as advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide you with a large range of specialized drug delivery devices, components, analytical services and regulatory support.
Becton, Dickinson and Company
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories.
Cytiva is a global provider of technologies and services that help advance and accelerate the development and production of therapeutic products. Promoting training, speed and efficiency for research and production workflows, allowing the delivery of innovative medicines to patients.
HEALTH SANITARY CONSULTING
Much of the strength and uniqueness of Health Sanitary Consulting comes from the continuous effort over time to interpret and apply health regulations in Mexico and the world.
The Laboratorios de Especialidades Inmunológicas (LEI) exist to ensure the Health of Mexico and the World through cutting-edge scientific analysis for the Human and Veterinary Pharmaceutical Industry, Cosmetics, as well as Clinical Analysis and Training. We are a Third Party Laboratory Authorized by COFEPRIS that since 1991 offers a unique catalogue with the most innovative studies on the market at the service of your needs.
We are a vibrant science and technology company. Science is at the heart of everything we do, it drives the discoveries we make and the technologies we create. For more than 350 years, curiosity has been driving us to deliver excellence to patients and customers – and to imagine the future.
The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In fiscal 2019, the company earned sales revenue of some 1.83 billion euros according to preliminary figures. At the end of 2019, more than 9,000 people work at the Group’s approximately 60 manufacturing and sales sites, serving customers around the globe.
We develop alliances with pharmaceutical companies, using Terumo technology to develop, manufacture and supply solutions to injectable drug delivery challenges. We pride ourselves on offering a portfolio of products and services for the pharmaceutical industry. By anticipating trends and maintaining a constant dialogue, we provide a first class customer experience.
UDIBI is a third-party laboratory authorized by COFEPRIS to conduct biosimilarity studies. Our experience is huge analyzing therapeutic biomolecules (recombinant hormones, cytokines, fusion proteins and monoclonal antibodies). Nowadays our capabilities have expanded to antibody engineering and development of antibody-based therapeutics. During the COVID-19 pandemic we developed products for research and diagnostic, highlighting our ELISA kit UDITEST-V2G to detect anti-SARS-CoV-2 antibodies.