So, what are biologics and how are they different from traditional chemical medicines?
Traditionally, development of medicine centered around the synthesis of small molecules in a laboratory. These are relatively simple (think of aspirin), consist of very few atoms and are usually taken orally. They can easily be produced in substantial quantities.
Biologics are produced in living systems3 and due to this there is some inherent variability4,5 in the characteristics of the final drug produced. Variability has been observed in different batches of the same biologic medicine because of the size of the molecule, and the method of manufacture. Because of this, the manufacturing process is more complicated than it would be for a small molecule drug. 6
Then what are biosimilars and how are they tested?Biosimilars are biological medicines that are highly similar to an approved biological medicine (known as the 'reference biologic'), with comparable efficacy and safety to the reference biologic.7 Biosimilars are different to generics, which are exact copies of original simple chemical drugs.
What does biosimilars mean to Samsung Bioepis?Samsung Bioepis view biosimilars as key players in the world of medicines. By keeping costs low, making medicines available for more patients and offering more options for clinicians, payers and other healthcare professionals, biosimilars are shifting the paradigm of biologics. The number of biosimilars in development and in production are ever-increasing, maintaining healthy competition in the medicine market and offering high-quality alternatives.
References in IMG