Humira, Enbrel, you see their ads regularly; they are part of a class of medications called biologics. Biologics provide relief for about 2% of America’s population at the cost of about 40% of the money we spend on pharmaceuticals. They are very expensive, rivaling the drugs used to treat cancer. The physicians who prescribed these drugs, predominantly rheumatologists released a position paper on biologics “generic” substitute, biosimilars. What are they saying?
Biologics and Biosimilars
Most of the medicines we use are not biologics but simple compounds created in Big Pharma’s factories. For these drugs, a generic equivalent is identical to the branded drug it is copying. To fast track generics, the FDA requires a single test demonstrating that the generic’s ability to be absorbed, excreted and utilized, it pharmacokinetics, is identical to the brand product and then allows its use for the same indications as for the brand product.
Biologics are complex molecules, modifying our immune responses to specific chronic inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, or irritable bowel disease. They are manufactured by placing genes into host cells who through transcription and translation provide the core protein. Biosimilars are biologics “generic” equivalents, except they are not.