In this fascinating interview, we explore the world of biosimilars with an expert in the field, German Huertas, Director of Jackleckerman. He guides us through the most profound aspects of this constantly evolving field, offering a unique perspective and years of experience in the pharmaceutical industry. German provides profound insights into biosimilars’ origin, impact, and future. Join us as we discover how these medications are revolutionizing access to healthcare worldwide.
ABRS: How did biosimilars emerge?
German Huertas: Biosimilars emerged from an intriguing intersection between law and biology. When the patents of innovative drugs expire, other companies can replicate these drugs. Legally, the difference lies in the patent, but there shouldn’t be a significant difference biologically. It’s like a recipe that can be reproduced. However, it’s important to note that even if a company develops innovative drugs, each batch may vary slightly in composition. By the way, the term “biosimilars” goes beyond just a word; it’s a regulatory term.
ABRS: How do biosimilars contribute to access to medicines?
German Huertas: Biosimilars open the door to quality medicine at a much more affordable cost. Innovative drugs are often prohibitively expensive for patients. However, being biologically identical, biosimilars offer the same efficacy at a considerably lower price, on average 30% lower! This democratization of access benefits directly governments, who are the main buyers.
ABRS: Is the design of 9 clinical trial services similar for biosimilars and innovative drugs?
German Huertas: Biosimilars may require a little more effort in their approval. The European Medicines Agency promotes greater availability of biosimilars, leading to strict standards. Although maintaining these high standards is necessary, efforts are being made to expedite the approval of clinical study management for biosimilars, considering that there are already studies conducted by the innovator based on the biosimilar’s biocompatibility. In the case of Latin America, this would bring significant opportunities for increased access to biosimilars.
ABRS: What are the main challenges in the development of biosimilars worldwide?
German Huertas: The biggest challenge lies in making production profitable. Although biosimilars offer exciting promises, the regulatory approval process can be time-consuming and costly. However, there is encouraging progress as agencies share more data and regulations that speed up development.
ABRS: Which therapeutic areas are biosimilars mainly focusing on?
German Huertas: Oncology is getting a lot of attention. Biosimilars mainly focus on small molecules and oncological treatments. A ray of hope for many patients.
ABRS: Do you think global political conflicts affect the development of biosimilars?
German Huertas: Surprisingly, not so much. Although challenges may arise in input prices, India and Europe, leaders in production, are not severely affected by political conflicts.
ABRS: How can we educate people and healthcare professionals about biosimilars?
German Huertas: This is where doctors play a vital role. They are the leading advocates for educating patients about the benefits of biosimilars. Additionally, it’s crucial to highlight the pressure that doctors often face to prescribe certain drugs due to clinic purchasing policies. Finally, governments should educate the general public about biosimilars, as they are the main buyers.
We thank German Huertas for generously sharing his invaluable insights on biosimilars. Through his expertise, we have gained a deeper understanding of clinical study management and its significant implications for improving healthcare accessibility.