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| Oncology Biosimilars |
Oncology biosimilars are the copied and licensed versions of those reference biologics that have undergone patent expiration. Unlike other drugs, biological drugs must be made in a living system, such as yeast, bacteria, or animal cells. Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.
Regulations for oncology biosimilars play an important role in maintaining both viability and balance between original and biosimilar products. Thus, regulatory authorities, such as Food and Drug Administration (FDA) and the European Medicines Agency (EMA) actively regulate the development and commercialization of oncology biosimilars. The U.S. FDA has approved biosimilars to treat various conditions, such as diabetes, cancer, rheumatoid arthritis, Crohn's disease, psoriasis, colitis, and more.
They are prescription drugs, so in the U.S., the FDA regulates how they are manufactured and delivered to the users. Oncology biosimilars can be used to treat the same diseases, in the same way, as the reference biological medicines. Biosimilar drugs are important because they have the opportunity to provide competitiveness in the market and expand patient access to critical drugs, much like the advent of generic drugs. Biosimilars also have no clinically meaningful differences from the reference product.
The tremendous relevance of biosimilars for cancer has also helped researchers in emphasizing the importance of oncology biosimilars. Some biosimilar drugs have been approved to treat certain types of cancer, and some have been approved to help manage side effects. Biosimilars are not new drugs, but rather they are copies of biological drugs that have been used to treat many diseases and conditions. Biosimilars may provide more treatment options, lower health care costs, and increase access to lifesaving medications.
Biosimilars are a growing drug class designed to be used interchangeably with biologics. FDA-approved biosimilars are safe, effective treatment options.
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