Biosimilars in Clinical Trials

Clinical trials impose validation of safety and efficacy, and biosimilars have contributed large share to the pipeline of clinical trials. These biosimilars are the therapeutic alternatives to the reference biologic drugs, developed through rigorous regulatory requirements. When a commercial biologic loses patent protection, there are augmented opportunities for launch of biosimilars. On the basis of clinical trials, a biosimilar can meet the requirements of approval. Once the safety and efficacy are proved, FDA approves the biosimilar via an abbreviated licensure pathway implemented under the Biologics Price Competition and Innovation Act (BPCIA) and licensed under section 351(k) of the Public Health Service (PHS) Act. As of now, most of the biosimilars are used for treatment of cancers, diabetes, autoimmune diseases, etc. Eventually, more of the biosimilar drugs are approved by means of clinical studies that result in cost-effective drugs for patients. Thus, due to the biosimilars treatments are more tailored, with novel therapies that can be developed, but those seems to be challenging. So, the sponsors/investigators of biosimilars need to understand these challenges and refer the FDA guidelines to facilitate and expedite approval. Thus, biosimilars present a potential for new plays in the industry that can act as a game changer for essential and critical drugs. The presented chapter acknowledges about biosimilar development, studies involved in clinical trials for biosimilars, considerations for clinical trials of biosimilars, regulatory complexities and challenges of biosimilars, challenges, and licensing of biosimilars with potential of biosimilars.