As experts in the field of biotherapeutic medicine meet in Rio de Janeiro on 24th-25th August in the run-up to the 16th International Conference of Drug Regulatory Authorities (ICDRA), they should capitalize on the opportunity to discuss the future of biotherapeutic therapies, as well as address the risk that non-comparable biotherapeutic products pose for patients and health systems globally
Undoubtedly, one innovation that has radically transformed medicines is the development of newer, more sophisticated type of drugs produced by living organisms called biotherapeutics. More than 350 biotherapeutic medicines have benefited to date some 400 million patients worldwide.
Biotherapeutics lead to more targeted therapies, better diagnostics and improved outcomes following a patient’s course of treatment for many of the world’s most prevalent diseases, as well as for less common conditions. Biotherapeutics include innovative products for the treatment of chronic diseases such as cancer, diabetes and rheumatoid arthritis, as well as for acute conditions such as myocardial infarction and stroke – and have two common denominators: biological origin and structural complexity. These products bring genuine differences in saving lives, reducing hospitalization and ultimately, contributing to healthier societies.
The challenges of manufacturing biotherapeutic medicines
Biotherapeutics are very complex molecules made in living organisms by genetically engineering DNA. As such, every step we take in the production of these medicines requires highly controlled testing to ensure consistent quality, safety, and efficacy. On average they undergo 5 times more testing compared to chemically-synthesized or conventional medicines. They are usually proteins that can be up to 1,000 times bigger than conventional drugs and are normally given by injection or infusion.
|How Biotherapeutics are made
Step 1: insert the DNA into host cells. Once the DNA is inside the cells, it uses the cells’ machinery to transcribe and translate the DNA message into the biologic.
Step 2: The most effective cell line is selected for expansion and is grown in bioreactors.
Step 3: The biologic is purified and tested to ensure its function and quality criteria are met.
Biotherapeutics, Biosimilars and Non Comparable Biotherapeutics
Once the data exclusivity and patent expires on an innovative biotherapeutic medicine, follow-on products can now appear on the market: these types of medicines are known as biosimilars and non-comparable biotherapeutic products. Let me try to give you a quick overview.
Biosimilar medicines, on the one hand, are developed and assessed through comprehensive clinical testing to demonstrate their therapeutic equivalence to the reference product. Basically biosimilars are highly similar to a biotherapeutic that has already been authorized by a national drug authority after the review of a full regulatory dossier. They are subject to tailored regulatory data package with side-by-side analytical and clinical testing and may have minor variations compared to original biotherapeutic reference product, but with no clinically meaningful differences identified.
On the other hand, non-comparable biotherapeutic products are medicinal products that are developed with limited or no side-by-side comparability exercises and have not been approved via a regulatory procedure in alignment with World Health Organization (WHO) principles. In other words, these products may or may not be similar to the original biologic medicine that they claim to be. When such medicines are used, patients could potentially be put at risk due to the unknown safety and efficacy of the product. The potential threat to public health is worrisome as continued use of these medicines could reverse years of hard-won progress in the research and development of safe and effective biotherapeutic medicines.
Call to action for biotherapeutic medicines
Government officials and drug regulatory authorities meeting at the ICDRA conference in Rio de Janeiro this week should capitalize on the opportunity to discuss the future of biotherapeutic therapies, considering that manufacturing a safe and effective biotherapeutic medicine requires tremendous effort and vigilance. Our industry is rigorously committed to quality, safety and efficacy as this is the only way to ensure that each dose will be to the patients’ benefit. Governments should adopt appropriate regulations and stringent regulatory processes in harmony with WHO principles to ensure quality, safety, and efficacy are achieved at all levels. This would help in addressing the risk that non-comparable biotherapeutic products pose for patients and health systems globally. What’s crucial in medicine is to ensure they are safe, improve patients’ health and do not pose any unnecessary risk.
For more, click on everything you need to know about ICDRA