Biosimilars LatAm – Brazil 2023
The 2023 edition in Brazil presents the next level discussion for Biosimilars in the country for the interest of producer companies. The interchangeability, as well as new developments and mechanisms supported by ANVISA, will be deeply discussed by authorities, industry leaders and CDMO experts to identify the opportunities that the Brazilian regulatory agency is interested in providing for more biosimilars access to the individuals. The new Latin American regulatory landscape is the central closing conversation with representatives from the biggest markets in the region that will set up the future of opportunities for the industry and patients. A forum that will mark the change for LatAm.
Industry Executives from Latam
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Business Development
Program at a Glance
Biosimilar Regulatory Updates, ANVISA
Brazil’s regulatory updates for biosimilars aim to strike a balance between promoting access to affordable treatment options and maintaining high standards of quality, safety, and efficacy. These updates foster a favorable environment for the development, approval, and use of biosimilars, ultimately benefiting patients and the healthcare system as a whole.
Exploring Butantan's Tech Transfer and PDP Projects
Partnerships for Productive Development (PDPs), as a unique collaboration involving a public institution, a private company, and the Ministry of Health, have resulted in great accomplishments to expand access to affordable biologic therapies for patients. These gain-gain relationships facilitate tech transfer, enabling the production of vital products for the Ministry of Health without competitive bidding. Butantan’s handling of the phases, milestones, and regulatory aspects of these projects are setting a positive trajectory for future advancements in the biosimilar sector.
Biosimilar’s Real World Data
By grounding the discussion surrounding biosimilars in real-world data and case studies, stakeholders can gain a deeper understanding of their value and impact. These examples validate the safety, efficacy, and economic benefits of biosimilars, fostering confidence and encouraging wider adoption in clinical practice, ultimately benefiting patients, healthcare systems, and society as a whole.
CDMO Usability in Other Mechanisms for Production in Brazil
While CDMOs in Brazil face challenges, their past and present success highlights their strengths as a mechanism for pharmaceutical production. Their potential for the future remains promising, particularly when combined with other production avenues provided by the Brazilian government. By leveraging partnerships, technological advancements, and regulatory support, CDMOs can contribute to the growth and sustainability of the pharmaceutical industry, benefiting both the sector and patients in Brazil.
Interchangeability in Brazil. Data and Analysis
Interchangeability of different molecules in Brazil requires careful evaluation from multiple perspectives, including healthcare professionals, patients, and the industry. Data and analysis play a crucial role in assessing the safety, efficacy, and regulatory considerations for interchangeability, ensuring informed decision-making, healthcare system sustainability, and fostering confidence in the use of interchangeable products.
Regulatory Agencies: New LatAm Landscape
The evolving regulatory landscape in Latin America reflects a commitment to strengthening regulatory systems, enhancing collaboration, and aligning with international standards with the ultimate goal of harmonisation. These efforts contribute to a more efficient, transparent, and patient-centered environment, fostering innovation, increasing access to medicines, and ultimately improving healthcare outcomes for populations all across in the region.
Full Programme in the PDF Agenda
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.
As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.
Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.
We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.
Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.
We listen. We question. We deliver.
With 60+ dedicated scientists and support personal, UDIBI is a third-party laboratory authorized by the Mexican Regulatory Agency (COFEPRIS) to conduct analytical services for the pharmaceutical and medical devices industries. We also provide consulting services on antibody engineering and development of antibody-based therapeutics. With the support from government and private investment we have developed a portfolio of biotherapeutics that includes a product in the market and several therapeutic antibodies in diverse phases of discovery, optimization and preclinical development. In response to COVID-19 pandemic, UDIBI developed and commercializes the only 100% Mexican diagnostic kit to detect anti-SARS-CoV-2 antibodies with approval by COFEPRIS for commercialization in Mexico.
Thermo Fisher Scientific is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivitin their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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.