healthCMI

Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options and help in lowering healthcare costs. Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires. These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children. The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ul...

Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options and help in lowering healthcare costs. Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires.  These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children. The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ulc...