Understanding the Difference and Importance of Biological, Biosimilar, and Interchangeable Medicines for Brazil, the USA, and the EU.

Introduction:

Biological medicines are complex molecules derived from living organisms, and they have revolutionized the treatment of several diseases, including cancer, autoimmune disorders, and diabetes. However, the high cost of biological medicines has limited patient access in many countries worldwide. In response, biosimilar and interchangeable medicines have emerged as cost-effective alternatives to biological medicines. This paper aims to discuss the difference and importance of biological, biosimilar, and interchangeable medicines in Brazil, the USA, and the EU.

Biological Medicines:

Biological medicines are innovative products developed through biotechnology, and they are used to treat complex diseases. Biological medicines have high molecular weight, and they require special handling, storage, and transportation. Due to their complexity and high development costs, biological medicines are usually expensive. In Brazil, the approval of biological medicines is regulated by the National Health Surveillance Agency (ANVISA) (1). In the USA, the Food and Drug Administration (FDA) is responsible for the approval of biological medicines (2), while in the EU, the European Medicines Agency (EMA) regulates the approval of biological medicines (3).

Biosimilar Medicines:

Biosimilar medicines are similar to biological medicines in terms of efficacy, safety, and quality. Biosimilars are developed using a different cell line or production process than the original biological medicine. Biosimilars have the potential to lower the cost of treatment for patients, as they are usually priced lower than biological medicines. In Brazil, the approval of biosimilar medicines is also regulated by ANVISA (1). In the USA, the FDA has developed a rigorous approval process for biosimilar medicines, which requires evidence of similarity to the reference biological medicine (4). In the EU, the EMA has established a regulatory framework for the approval of biosimilar medicines (5).

Interchangeable Medicines:

Interchangeable medicines are a subset of biosimilar medicines that can be substituted for the reference biological medicine without the intervention of the healthcare provider. Interchangeable medicines are expected to provide the same clinical result as the reference biological medicine. In Brazil, there is no specific regulatory framework for interchangeable medicines (1). In the USA, the FDA has established guidelines for the approval of interchangeable medicines, which require additional evidence of similarity and interchangeability with the reference biological medicine (6). In the EU, the concept of interchangeability is not yet established (3).

Conclusion:

Biological, biosimilar, and interchangeable medicines have revolutionized the treatment of several complex diseases. The high cost of biological medicines has limited patient access in many countries worldwide. Biosimilar and interchangeable medicines have emerged as cost-effective alternatives to biological medicines. In Brazil, the approval of biological and biosimilar medicines is regulated by ANVISA, while in the USA and the EU, the approval is regulated by the FDA and EMA, respectively. The concept of interchangeability is not yet established in the EU, while the FDA has developed guidelines for the approval of interchangeable medicines in the USA. It is important to ensure that the approval process for biological, biosimilar, and interchangeable medicines is rigorous and evidence-based to ensure patient safety and efficacy.

References:

National Health Surveillance Agency (ANVISA). Biological Products. Available from: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/biologicos. Accessed on 22 February 2023.

Food and Drug Administration (FDA). Biological Products. Available from: https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/biological-products. Accessed on 22 February 2023.

European Medicines Agency (EMA). Biosim