Biosimilars LatAm – Mexico 2024

The 2024 edition in Mexico aims to provide insights into local and international regulatory matters, explore biobetters and next-generation biologics, discuss the impact of biosimilar licenses on pharmaceutical innovation in Mexico, and delve into the evolving landscape of nearshoring and newshoring strategies in the industry.

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

Speaker Board

Program at a Glance

Biosimilar Regulatory Updates

In Mexico, the Federal Commission for the Protection against Sanitary Risks (Cofepris) has significantly improved access to biotechnological and biosimilar medicines by simplifying the approval process and accepting clinical data from other countries. By recognizing standards from the World Health Organization (WHO) and the Pan American Health Organization (PAHO), Cofepris has facilitated the evaluation of these products. These regulatory modifications not only accelerate the availability of biosimilars but also reduce costs, providing essential therapeutic options in areas such as oncology and autoimmune diseases, ultimately benefiting both patients and the healthcare system.

Invited: COFEPRIS

Biobetters and Next-Generation Biologics

The next generation of biologics, including biobetters, promises even more specific and effective treatments. This is crucial for addressing complex diseases such as cancer, autoimmune diseases, and rare diseases. Research and development in this field are constantly evolving. Scientists are working to optimize biobetters to achieve a balance between efficacy, safety, and accessibility.

Streamlining Biosimilar Approval: MHRA's Approach to Waiving Comparative Efficacy Testing

The Impact of Biosimilar Licenses on Pharmaceutical Innovation in Mexico

The regulatory strategy implemented by the Mexican government, through COFEPRIS, has created a competitive environment that not only reduces the costs of biological treatments but also encourages companies to invest in research and development of new therapies. However, these benefits have not quelled the debate over the impact of biosimilars on continuous innovation.

Benefits and Challenges of Regulatory Harmonization Efforts in Latin America

Nearshoring is Dead, Long Live Newshoring

The panel aims to explore the benefits and challenges of regulatory harmonization efforts in the biosimilar industry, focusing on how streamlined processes can facilitate drug manufacturing and market access. Designed for an audience of pharmaceutical industry executives, the discussion will highlight best practices and lessons learned from various regulatory environments, including insights from Asia. This global perspective will offer valuable takeaways for businesses looking to expand their reach beyond Mexico, emphasizing how international collaboration can drive innovation and improve access to affordable, high-quality biosimilars across different markets.

Full Programme in the PDF Agenda

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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.

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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.

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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.

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INFORS

For over 55 years, INFORS HT has been developing and producing high-tech solutions for biotechnology. We are proud to be one of the best in the field of specialists for bioreactors, shaker incubators and bioprocess control software.

Much has changed since the company was founded in 1965. The Spirit of INFORS HT, however, remains the same. In keeping with our company creed—“We firmly believe you can make anything better”—we commit ourselves each and every day to simplifying our biotechnology customers’ workflows through the use of the most modern technologies available.

To achieve that, we directly involve our customers during the product development stage, which allows us to design highly practical products, software solutions and services that make good on our promises—not just on paper, but in the challenges of everyday operations as well.

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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.

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MCD LAB

MCD LAB is a national manufacturer of medical devices, including culture media, peptones, and agars, used for bacterial cultivation.

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Testimonials

”It was an excellent opportunity to hear what the authorities industry, even sometimes what our competitors or other providers have to say about the topic.”

Alison Bascou, Sr. Regulatory Director at BD, France
"I think it's being an interesting event. Wherever there's discussion at top level, wherever there's respect. wherever there's an open forum, science can advance. It's very important to keep patient's well-being in mind and I think this forum allows that."

Jaime Uribe, CEO At PROBIOMED
“The strength of the biosimilar industry in our region is very encouraging. It seems to me this event is the propitious forum to share experiences and it is great.”

Tammy Boggiano Ayo, Process Development Director at CIM, Cuba
“It showed a broad picture, from a highly technical perspective up to a commercial viewpoint. It is not easy to get that in such a short period of time.”

Santiago Salguero, Executive Director at Pharmaceutical Association of Ecuador
“For companies like those I work for, i.e. suppliers to the pharmaceutical industry, this has been a great opportunity to see our clients’ perspective and above all to identify the major trends determining the future of biosimilars.”

Mauricio Roberto Hernández Morales, Key Account and Business Developer Manager at BD Mexico