We are are committed to providing cost effective treatments for the NHS and pharmacies in the UK. As part of the STADA group, our range is constantly evolving and we are always innovating in this area.
Generics are pharmaceutical products that contain the exact active pharmaceutical ingredient as the original patented product of the initial supplier. Despite their high quality, generics are substantially cheaper.
Biosimilars are copies of biotechnologically produced drugs, so-called biopharmaceuticals. These are active substances obtained from living cells of plants or animals. Biopharmaceuticals now play an important role in the treatment of many serious diseases such as osteoporosis, arthritis and cancer. Compared to generic drugs, i.e. copies of chemically produced drugs, biosimilars require considerably more time and effort for the development as well as control of the manufacturing process and require a significantly bigger amount of data that must be submitted for approval. One reason for this is that the structure of biotechnological drugs is much more complex than that of chemically produced drugs. On the other hand, the complex production process within living organisms leads to natural fluctuations also present in the original medicine. This also means that biosimilars are never identical copies of the original preparations. However, the differences must be kept within strict limits to ensure comparability of the biosimilar with its reference product. For companies producing biosimilars, these narrow limits result in high investments – whether for development, clinical studies, quality assurance in high-tech production processes or approval. With this final step the respective competent authority confirms that the biosimilar is equivalent to the original product in terms of efficacy, quality and safety. A biosimilar medicine is developed to be highly similar to an existing biological medicine (“reference medicine”), meaning that they are essentially the same.
For SmPC and PILs follow the links which will take you to the electronic Medicines Compendium (emc) website which is a non-Thornton & Ross website. https://www.medicines.org.uk/emc/.
Last updated: January 2020 TR-001