earticle

영어

The global market of Bio drugs has increased substantially during the last decade since the introduction of recombinant insulin in 1982. The intellectual properties of these bio drugs are beginning to expire, so that the attention of biosimilar products has increased since the European government published the regulatory guideline for biosimilar products in 2005.
Due to the heavy financial burden of health care budget by use of expensive innovative bio drugs, governments of industrialized countries are very active on the approval of biosimilar products. Biosimilar products, however, are facing significant challenge of the successful marketing. Intense competition among major pharmaceutical companies, heavy development cost of the products globally and significant challenge by original drug makers cast doubts on the success of Biosimilars in the future. The advance of new drug delivery technology such as longer acting bio drugs enables the companies to develop “Bio‐better” products. At present, the global market of bio drugs is moving toward the bio‐better products. The long acting biobetters are adding values to the existing bio drugs and thus increasing the market size of total bio drugs. Development of Bio‐better is the main focus of the drug development among major harmaceutical companies and new long acting technology is much anticipated. Alteogen Inc developed a new proprietary long acting technology using a carrier molecule called NexPTM.
Protein drugs such as hGH, GCSF or interferons are genetically fused to NexPTM, and these fusion bio drugs showed substantially improved PK profiles which are expected to be suitable for weekly or bi‐weekly injection cycle rather than daily or bi‐daily injections of the original bio drugs. NexPTM fused bio drugs also demonstrated impressive in vivo biological efficacies shown by PD experiments in animal models. NexP fused bio‐betters, therefore, can be a uccessful model for bio drug development targeting global market and eventually replacing very crowded and low profit biosimilars with technical edge.