Biosimilars LatAm – Brazil 2024

The 2024 edition in Brazil aims to delve into the hurdles of producing monoclonal antibodies locally, discuss effective strategies for navigating the complex landscape of biosimilar licensing in Brazil, and explore the economic implications of biosimilar usage, focusing on cost savings, accessibility, and the evolving market dynamics in the country.

 

Who will
you meet?

 

More than:

Participants

Companies

HCPs

Patients

Academy

Investors

Institutions

Associations

Service Providers

Government Agencies

Industry Executives from Latam

From these areas:

  • Biosimilars
  • Biobetters
  • Biotechnology
  • Biotherapeutics
  • Analytical science
  • Regulatory compliance
  • Quality Control
  • Clinical immunology
  • Scientific Affairs
  • Pharmacovigilance
  • Research
  • Regulatory
  • Business Development
  • Marketing

Plan Your 1-to-1 Meetings with JackLeckerman App

1. JackLeckerman App: Login & Meeting Notifications

Download the JackLeckerman App and sign up.

Check your email for the login details, or use the “Forgot Password” option to retrieve them.

You will receive meeting reminders on your mobile over the 2 days.

These reminders will include meeting requests, meeting confirmations, and messages from other attendees and the coordinator.

2. Attendee list to Plan Your Meetings

Browse the attendee list and select someone for a 10-minute 1-to-1 Meeting request.

Meeting requests close one hour before each Networking session in the program.

3. Managing Meeting Requests, Your Meetings Schedule

Accept or decline meeting requests through the “Meetings” button.

Check your scheduled meetings for the upcoming networking break.

4. Meeting Point Location in the Coffee Break Area

Go to the coffee break area and find the table number to meet your colleague

Speaker Board

Program at a Glance

Biosimilar Regulatory Updates
The Road to Reliance between Brazil and Portugal

Brazil and Portugal have been working on mutual reliance on biosimilars to improve healthcare accessibility and cost-effectiveness. Emphasizing biosimilar development, both nations aim to expand treatment access while ensuring affordability. This shared commitment fosters collaboration and innovation within their healthcare systems, promoting the adoption of safe and effective biosimilar therapies. By leveraging their collective expertise and resources, Brazil and Portugal can further enhance patient care and advance towards sustainable healthcare solutions.

Harmonizing Global Standards for Biosimilars: Insights from ICH Guidelines

The ICH guidelines for global biosimilar standards aim to harmonise regulatory approaches across regions, ensuring consistent evaluation and approval processes. These guidelines cover quality, safety, and efficacy requirements, focusing on the comparability of biosimilars to reference biologics. By standardising analytical techniques, clinical trial designs, and pharmacovigilance practices, the ICH guidelines help streamline biosimilar development, facilitate international collaboration, and enhance access to safe, effective, and high-quality biosimilar medicines worldwide.

Challenges in Local Production of Monoclonal Antibodies

Brazil faces challenges in local production of monoclonal antibodies, a critical area for healthcare. These challenges include technological limitations and complex regulatory processes, hindering domestic production. With a growing demand for these advanced therapies, Brazil seeks to overcome these obstacles through strategic partnerships and investment in research and development. This effort aims to strengthen local capabilities and ensure broader access to vital monoclonal antibody treatments.

Navigating the Landscape of Biosimilar Licensing: Strategies for Successful Market Entry in Brazil

Navigating the landscape of biosimilar licensing in Brazil requires a nuanced approach due to its intricate regulatory framework. Companies aiming for successful market entry must navigate approval processes, pricing negotiations, and local partnerships. Understanding these complexities and employing tailored strategies, such as leveraging data exclusivity periods and engaging with key stakeholders, can pave the way for a fruitful entry into Brazil’s biosimilar market.

Economic Impacts of Biosimilar Administration in Brazil: Cost Savings, Access, and Market Dynamics

The economic impacts of biosimilar adoption in Brazil are significant, with cost savings, improved access to treatments, and evolving market dynamics. The widespread use of biosimilars in the country’s healthcare system leads to substantial savings for patients and the healthcare industry. This trend also fosters competition among manufacturers, driving down prices and expanding accessibility to vital biologic therapies.

The Role of the Program for Local Development and Innovation in the Brazilian Biosimilar Landscape

Unlike the PDP Program, which focuses on building national capacity through technology transfer from private companies, the PDIL aims to reduce the production and technological vulnerability of Brazil’s Unified Health System (SUS) by fostering local development of innovative solutions. the Ministry of Health would select projects regularly submitted to the Secretariat of Science, Technology, Innovation, and Health Complex (“SECTICS”), as well as projects submitted in response to public calls. Support would be formalized through any instruments aimed at promoting innovation. This initiative aims to bolster local production and technological development in Brazil’s healthcare sector, including the advancement of biosimilars.

Best Practices for Conducting Comparability Studies in Biosimilar Development

Ensuring the quality, safety, and efficacy of biosimilars requires adherence to rigorous comparability studies. Best practices encompass comprehensive analytical and functional assessments, including physicochemical, biological, and immunological characterizations. Moreover, careful selection of reference products, study design, and statistical analyses is paramount. These practices mitigate risks associated with biosimilar development, fostering regulatory approval and confidence among healthcare professionals and patients in the therapeutic equivalence of biosimilar products.

Full Programme in the PDF Agenda

Download Agenda

Sponsors

Merck

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.

Terumo

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. 

UDIBI

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.

Cytiva

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.

Sartorius

Based in Goettingen | Germany, Sartorius is a leading international partner of life sciences research and the biopharmaceutical industry. With its two divisions Lab Products & Services and Bioprocess Solutions, Sartorius helps customers to manufacture biotech medicines, vaccines, and cell and gene therapies safely, rapidly, and economically.

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