Biological products including biosimilars are large and generally complex molecules
Custom Synthesis, When the patent on the cancer drug trastuzumab (Herceptin) expires next year, patients who have been receiving this biological therapy will have another treatment option: a biosimilar drug—a drug that is very similar, but not identical, to trastuzumab.
Last fall, the Food and Drug Administration (FDA) approved the first trastuzumab biosimilar for the treatment of some breast and stomach cancers based on research showing that, in terms of safety and effectiveness, the drug was comparable to trastuzumab.
To be approved as a biosimilar, a drug must be highly similar to the original biological drug—in this case, trastuzumab. And in terms of safety, purity, and potency, there can be no clinically meaningful differences between the biosimilar and the original product, which FDA calls the reference product.
When the trastuzumab biosimilar, trastuzumab-dkst (Ogivri), becomes available in 2019, it could be part of a wave of new biosimilars for patients with cancer.
“To date, eleven biosimilars have been approved in the United States, but nearly 70 more are in the development pipeline,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in FDA’s Office of New Drugs, noting that the patents on some widely used biological drugs will expire in the coming years.
“The main advantage of biosimilar products,” Dr. Christl continued, “is that they can provide additional treatment options and create market competition, potentially lowering the costs of treatment and enabling greater access to biological therapies for more patients.”http://www.haihengpharma.com/biological-products-including-biosimilars-are-large-and-generally-complex-molecules/News