Innovative biological drugs are pharmaceutical products made from living organisms using advanced biotechnological processes. They are often used to treat chronic or serious diseases, such as cancer, diabetes or autoimmune diseases. On the other hand, biosimilars are versions of these innovative drugs that, although not identical, are highly similar in terms of safety, effectiveness and quality. These medicines can be classified into several categories, such as monoclonal antibodies, therapeutic proteins and vaccines, each with specific storage and transportation requirements.
Logistics in the biologics and biosimilars sector plays a crucial role in ensuring that these products reach their destination in optimal conditions. Given their sensitivity to factors such as temperature, humidity and exposure to light, an efficient and secure supply chain is essential. Inadequate management can compromise the efficacy of the product, putting the health of patients at risk and generating significant economic losses for the industry. What are the challenges facing logistics?
- Cold chain and product stability: these medicines require controlled temperatures, often between 2°C and 8°C, although some may require more extreme conditions, such as deep-freezing at -70°C.
- Specialized infrastructure: warehouses and transports equipped with real-time monitoring technology are required to ensure product stability.
- Strict regulations: every country has specific regulations for the import, storage and distribution of these products.
- Risk control: the possibility of losses due to refrigeration failures, customs delays or improper handling is a constant challenge.
- Traceability and security: the implementation of tracking systems to verify the location and condition of the product at all times is essential.
- Compliance with good practice: management must follow strict Good Distribution Practices (GDP) to avoid contamination or alteration of the product.
A company specializing in the logistics of innovative biologic drugs
Customs management and regulatory compliance are key issues in the logistics of biologics and biosimilars. Customs authorities establish rigorous controls to prevent the entry of counterfeit products or products in inadequate conditions. In addition, there are specific tariffs and regulations that vary according to the legislation of each country or supranational region, which forces logistics companies to adapt to each market.
Companies specializing in pharmaceutical logistics must comply with international regulations such as those established by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). This requires certified warehouses, conditioned transportation and personnel trained in the handling of these products. In addition, accurate documentation and correct product declaration are essential to avoid delays and penalties.
At Airpharm we specialize in pharmaceutical logistics, with extensive experience in the management of biological and biosimilar drugs. Our state-of-the-art infrastructure, compliance with international regulations and highly trained team guarantee safety and efficiency in the transportation and storage of these products. If you want your pharmaceutical logistics to be safe, efficient and tailored to your needs, contact Airpharm now.
