Biosimilar approval and checkpoints

Abstract

Biologic drugs and subsequently developed biosimilars treat chronic inflammatory autoimmune conditions such as rheumatoid or psoriatic arthritis, ankylosingspondylitis, crohn's disease, ulcerative colitis, and psoriasis. Biologics can target the cancer in a specific way and may work synergistically with chemotherapy to improve outcome. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the biologic drugs which are authorized for sale. The global market for Biosimilars is dominated by oncology (nearly 39% share) whereas the total biosimilar market size is expected to reach nearly 70 billion by 2025. Biosimilars are generally marketed at prices 25 to 40 percent below original branded productsie Biologics. The number of biosimilars approved by US FDA are nearly 30. There are about 25 top global manufacturers of biosimilars. Many Domestic companies in India are making strong presence even in regulated markets. (BPCIA) guidelines in the United States (US), mention that a biosimilar can be designated as “interchangeable”, whereby it may be substituted for the reference product (original biological drug).