Physician Notice of Biologic Substitutions
Unlike generic drugs, biosimilars are derived from living cells and are not chemically identical to their reference product (the original brand name biologic). As their name implies, they are only similar. While a biosimilar may be deemed â€˜interchangeableâ€™ to a biologic and, therefore, substitution is permitted, there are patient-related, disease-related, and product-related factors that could influence the immune response to these drugs. By their very nature, biologic medications are very complex and sensitive drugs which treat serious and sometimes rare diseases. Correspondingly, they can have very serious and unpredictable side effects not seen in other drug classes.
To ensure patient safety, it is important that you are notified when a biologic you prescribed is substituted with a biosimilar. While the Pennsylvania Medical Society (PAMED) is not suggesting that physicians want to hinder substitution, biologic medicines and their biosimilar counterparts are substantially different from conventional drugs.
While the FDA has yet to approve any biosimilars or interchangeable biosimilars, they are expected to be on the market in the coming years. SB 405 also would ensure that when these new drugs are approved, Pennsylvaniaâ€™s laws appropriately address them.TAKE ACTION HERE
Payer Contracts: What Medical Practices Should Know
Pennsylvania Physicians and medical practices will be facing a host of new payer contracts over the coming year. PAMED's Mary Ellen Corum walks you through common pitfalls.