Biosimilars - Safe and Effective?

According to the FDA, biosimilars are safe and effective medications for treating many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. Generally made from natural sources - complex molecules manufactured using living microorganisms, plants, or animal cells. Many are produced using recombinant DNA technology. They're sometimes referred to as biopharmaceuticals or biological drugs. Some examples of biologics are: Humira, Rituxan, Enbrel, Herceptin, Avastin, Remicade, Lantus, Neulasta, Avonex, and Lucentis. Biological products can include a wide range of products including: vaccines, blood components, gene therapy, tissues, and proteins, like monoclonal antibodies and cell signaling proteins.

All of the above mentioned biologics have exceeded the monetary dreams of their respective pharmaceutical companies, generating more than $1 billion in annual sales, according to 2017 sales data reported by drug manufacturers.

Most drugs are chemicals synthesized from other chemicals, however, biologics are much more expensive owing to their complex manufacturing process. Because of the high cost, there is a huge demand for generic versions of biopharmaceuticals. Several pharmaceutical companies are lobbying for permission to manufacture generic versions, but because they are so complicated to manufacture, there is concern about their ability to manufacture generics safely and reliably. Reducing costs is one reason Congress created the FDA approval pathway for biosimilar medications. However, FDA does not regulate whether insurance companies cover or reimburse the cost of biosimilars.

Compared with their original biologics, a biosimilar is highly similar to a biological medication already approved by the FDA – the original biologic (also called the reference product). Biosimilars also have no clinically significant differences from the reference product. Practically, one can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product. Biosimilars are made with the same types of natural sources; given the same way; provide the same treatment benefits; have same potential side effects; are given in the same strength and dosage; many available by autoinjector, infusion bag, or medication vial; and may provide patients with more access to important treatments. Very importantly also, costing less, they bring lower costs to the consumer healthcare market. Some examples of FDA approved biosimilars are: Zarxio and Nivestym (biosimilars to Neupogen), Inflectra (biosimilar to Remicade), Erelzi and Eticovo (biosimilars to Enbrel), and Amjevita (biosimilar to Humira).

Following the lead from European countries, biosimilar approvals are now achieving acceptance quickly in the U.S. 

Biosimilars are like generics in some ways, in that, both types of medications are compared to a reference (original) product for approval. Biosimilars and generics are both versions of previously FDA approved medications and may offer more affordable treatment options to patients. There are differences between biosimilars and generic drugs. For example, biosimilars are generally made from natural and living ingredients and generics are often made from chemical ingredients. In contrast to a chemical, which is synthesized and can be generally copied, a biologic medication is made from natural and living sources and cannot be exactly copied. So, the information needed to demonstrate that a biologic is biosimilar to another biologic can be much more extensive than what is needed for a generic.

The process by which FDA makes sure biosimilars are as safe and effective as the original biologic is multi-tiered. Biosimilars are approved after an extensive review of data, studies, and tests.  Any differences between the proposed biosimilar product and the reference product are carefully evaluated by FDA to ensure the biosimilar meets FDA’s approval standards. Medication quality is checked during production. Safety and effectiveness are monitored after approval. However, it is worth noting that biosimilars and generics are approved through different abbreviated pathways than biologics, to avoid duplicating certain costly clinical trials.

©2022 Guiomar Goransson