Providing access to affordable biological products and medications is important
Because of the complexity of these medications patient safety must be the first priority
Substitution should only occur for FDA approved "interchangeable" biologics
Physicians should be able to order specific medications when needed and should be notified of all substitution changes as soon as possible
Rheumatologists are keenly aware of the dramatic and life changing clinical improvements that biological products have on some of the most disabling conditions that affect Americans. These drugs are available for the treatment of rheumatoid arthritis, psoriatic arthritis, and other autoimmune diseases and have a significant impact on improving our patients’ quality of life, preventing disability, decreasing morbidity and lowering mortality.
Because of the complexity of creating these drugs, it is virtually impossible to create identical “generic” products of biologics. Instead, biologics have what are called biosimilar or interchangeable biological products that meet varying degrees of similarity.
The Patient Protection and Affordable Care Act (ACA) in 2010 created a regulatory pathway for the approval of follow-on biologics (also known as biosimilars or interchangeable biologic products) through the Biologics Price Competition and Innovation Act. The law creates pathways for “generic” type biologic drugs with the highest tier being “interchangeable.” In order for a biologic product to be deemed interchangeable with an innovator product, the FDA must determine that a biologic is biosimilar and expected to produce the same clinical result as the innovator product.
Currently, all state laws allow the pharmacist to substitute a less expensive generic product for the brand name product. Most states do not recognize the differences between biologics and chemically synthesized drugs and lack safe notification requirements for biologic substitutions. With FDA approval of the first biosimilar product in 2015, state legislatures must weigh proposals to regulate the substitution of biologic prescriptions.
CSRO recognizes that biosimilars are a natural evolution of biotechnology and welcomes the introduction of these medications. However, pharmacists should only be authorized to select a biosimilar when filling a prescription for a prescribed biological product if the FDA has designated it as interchangeable and the physician has not indicated not to substitute. The prescribing physician must be notified in a timely manner whenever a patient’s biologic medicine is substituted.