Biosimilars are biologic drugs that are highly similar to an already approved reference biologic medicine but not exactly similar in molecular structure. They are developed following the expiration of the patent on the original product and provide a lower price treatment option without lessening the safety or efficacy.
Introduction
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Overview of Biosimilars: Biosimilars are viewed increasingly within the pharma market as a crucial solution to increasing access to life-saving medicines relative to the diseases associated with oncology, autoimmune diseases, and chronic diseases.
As an example, biosimilars are changing the practice of medicine in the treatment of conditions such as rheumatoid arthritis, Crohn's disease, and various cancers where biologics are prevalent. With more biosimilars available, there is increasing demand for production facilities to produce the biosimilar and establish principles for efficiency and proven capabilities to get the biosimilar to market timely, decrease variability and provide consistency.
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Why Brazil is Taking Center Stage in Biosimilar Production: Brazil is quickly becoming a location of choice for biosimilar production in Latin America. Brazil possesses a solid pharmaceutical infrastructure, cost-effective and affordable production options, and the availability of a readily accessible labor force that makes Brazil a compelling environment for biosimilar development and production. Brazil is also a significant economy within Latin America and can serve as a distribution hub for the entire region, particularly for the other countries in Latin America and beyond.
Top 10 Contract Manufacturers in Brazil for Biosimilars
1. Biolab Sanus
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Specialties: Biologics, biosimilars, and injectables.
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Certifications: GMP, ANVISA approved.
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USP: Biolab is one of Brazil's leading pharmaceutical companies, and they have a strong focus on biologics and biosimilars. They offer services in contract manufacturing and research for a variety of biologic drug categories, including monoclonal antibodies.
2. Eurofarma
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Specialties: Generics, biosimilars, and active pharmaceutical ingredients (APIs).
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Certifications: GMP, ANVISA, ISO certifications.
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USP: Eurofarma is a large Brazilian pharmaceutical company with a strong presence in biosimilars, especially in oncology. They manufacture biosimilars in partnership with international organizations.
3. EMS Pharma
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Specialties: Generic drugs, biosimilars, and biotechnology products.
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Certifications: GMP, ANVISA, ISO 9001.
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USP: EMS Pharma is one of Brazil’s largest pharmaceutical companies. They have invested in biosimilar manufacturing and have the facilities and technology to support contract manufacturing for complex biologics.
4. Biosintética
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Specialties: Biosimilars, vaccines, and injectables.
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Certifications: GMP, ANVISA certified.
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USP: Specializes in manufacturing biosimilars and biotech products. They are known for their expertise in cell culture-based processes for biologics production.
5. Aché Laboratórios
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Specialties: Biologics, generics, and biosimilars.
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Certifications: GMP, ANVISA approved.
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USP: Aché has expanded its portfolio to include biologics and biosimilars, leveraging cutting-edge technology to produce high-quality biosimilar medicines for the Latin American market.
6. Libbs Farmacêutica
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Specialties: Oncology, immunology biosimilars.
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Certifications: GMP, ANVISA, ISO.
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USP: Libbs is a leading pharmaceutical company in Brazil with a focus on biologics. They are known for developing and manufacturing biosimilars in oncology and immunology.
7. Bionovis
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Specialties: Biosimilars, monoclonal antibodies, biotechnology.
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Certifications: GMP, ANVISA certified.
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USP: Bionovis is dedicated to the development of biosimilars, and they collaborate with local and international partners for contract manufacturing of biologics and biosimilars.
8. DGLAB
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Specialties: Biosimilars and biotechnology products.
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Certifications: GMP, ANVISA certified.
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USP: DGLAB is known for its expertise in biologic production and biosimilars, with a focus on monoclonal antibodies and other biologic therapies.
9. FarmaBrasil
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Specialties: Biotech products, biosimilars, and vaccines.
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Certifications: GMP, ANVISA certified.
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USP: FarmaBrasil offers contract manufacturing services for biosimilars, vaccines, and biotechnological products, catering primarily to the Latin American market.
10. Biogenesis Bago
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Specialties: Biologics, biosimilars, and therapeutics for oncology.
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Certifications: GMP, ANVISA approved.
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USP: This company focuses on providing affordable biosimilars, particularly for cancer therapies. They are a recognized player in Latin America’s biosimilar market.
Important Considerations When Selecting a Biosimilar Contract Manufacturer
Regulatory Recognition: When selecting a biosimilar contract manufacturer, it is critical to work with companies who have significant experience working with and are well-respected by Brazil's ANVISA, as well as having solid international biosimilar experiences. Manufacturers that can show strong regulatory expertise, will help to facilitate the approval rates of your products and adapt to working with the world's most stringent regulatory overview.
Global Compliance: Ask the manufacturer if they comply with international standards, i.e. EMA and the US FDA, in addition to ANVISA's standards.
Manufacturing Capacity: For biosimilar products manufacturing capacity is important for their demand fulfillment. To evaluate a contract manufacturers manufacturing capacity is vital to determining that they are able to maintain your scale requirements and your required product consistency.
Capacity for the mass production: It is important to determine that the manufacturer has up-to-date capabilities for mass production for the fulfillment of current and future demands as demand for the biosimilars grows.
Quality Control and Assurance: Another important consideration in a biosimilar manufacturing outsourcing decision is quality assurance and quality control. Ensure that the contract manufacturer follows strict GMP standards in addition to having procedures for ongoing quality testing throughout the manufacturing process.
Certifications: Confirm that they have GMP certifications or approvals from ANVISA, if applicable, or at the very least documented verifiable quality control protocols.
Technology and Innovation: The introduction of innovative biomanufacturing technologies is important for the economical manufacturing of biosimilars. Manufacturers who are implementing innovative technologies for example cell culture, purification technology, and high throughput screening will manufacture complex biologic products with competitive pricing.
Organizations that discover and take advantage of the newest biotechnologies will be able to benefit from shorter timelines to market, greater efficiencies, and a more consistent product.
Pricing and Flexibility: Pricing flexibility is critical for outsourcing the contract manufacturing of biosimilars. Biosimilar Contract manufacturers must deliver pricing structures relevant in cost/component or by volume; time; or project complexity. Flexible contract terms will give business the option to scale-up or scale-down based on need without compromising production timelines.
Summary:
Outsourcing biosimilar manufacturing to Brazil can yield a number of advantages from cost advantages and regulatory compliance, to a well-established pharmaceutical infrastructure. As international quality standards increase in importance Brazil is establishing itself as a location of choice for biosimilar production because it offers reliable costs, competitive costs, numerous manufacturing options for the pharmaceutical sector. With the increase of global demand for biosimilars, Brazil offers reliable costs with a skilled workforce located in a convenient location in Latin America. At the same time, if you are looking at expanding to Latin America or simply reducing manufacturing costs for biosimilars, Brazil is a great option for biosimilar manufacturing.
Conclusion
These 10 companies are leading the way for biosimilar manufacturers in Brazil, providing services through the entire process from research and development to commercial-scale production. Brazil is an appealing option for contract manufacturing in the biosimilar space with its infrastructure in the ever-growing pharmaceutical production industry and these manufacturers provide worthwhile services in working with pharmaceutical companies to develop and bring affordable biosimilars to market.