Prescribers, Pharmacists and Patients

Due to safety concerns over the use of biosimilars by physicians, pharmacists and buyers/users, laws and regulations on biosimilars by state legislations may vary, yet they all include the following features and requirements:

  • FDA Approval: Any biological medicine under consideration for substitution must first be approved as "interchangeable" with its reference product by the U.S. Food and Drug Administration.  By interchangeability, it means that a biosimilar has all of the reference product indications—as long as it works through the same mechanism in those diseases. Dr. Michael A. Morse, a medical oncologist from Durham, NC, said this about biosimilars, “Unlike with generics, the FDA requires that a biosimilar be ‘highly similar’ to the existing biologic reference product with no clinically meaningful differences in safety, purity, and potency.

  • Prescribers Decide: Federal legal framework and local interpretations and variations in legislation aside, acceptance of a biosimilar is dependent on how different stakeholders act. physicians, patients, pharmacists, 3rd party payers, policy makers. The prescribers (a physician, oncologist, physician assistant, etc.) could prevent substitution by stating “brand medically necessary.”

  • Prescriber Notification:  According to bills enacted in 2013-2014, the prescriber "must be notified" of any allowable substitution made at a pharmacy. As a matter of fact, most bills require that pharmacists notify prescribing physicians of the availability of a switch without any requirements on a timeline. However, the language commonly has been adjusted to say "communicate with" in bills passed in 2015 to allow a notation in an electronic medical record (EMR), PBM records or "pharmacy record that can be electronically accessible by the prescriber."  The improved legal framework and new pharmacological system would have allowed a physician to assess and compare the patient experience, but not to delay the transaction.

  • Patient Notified:  The individual patient must be notified as well that a substitute or switch has been made.  Relevant stipulations have been included in provisions regarding biosimilars in at least 20 states. In some cases, state law would require patient consent before any such substitution is made.

  • Records: The pharmacist and the physician are required by law to retain records of substituted biologic medications for a certain period of time, such as two or three years; the length of time may vary in different states.

  • Immunity: Pharmacists are among the most trusted health care professionals in America given guidance to millions of patients who rely on them on how best to take their prescription and over-the-counter medications. In the hospital, retail and community pharmacy settings, pharmacists counsel patients, dispense medicines and collaborate with doctors and health plans everyday. It is essential that they themselves are educated and current on the latest developments in disease treatment, including the use of biosimilars.[1] However, some state legislation provides legal immunity for pharmacists who make a substitution in compliance with biologics state law. Meanwhile, the state  must maintain a public or web-based list of FDA approved interchangeable products.

  • Cost or Pricing: Estimates have been made that biosimilars have generated a huge margin of savings for not only patients but also to commercial payers. A five-year cost savings of $256 million, of which 18% ($47 million) are from reduced patient out-of-pocket costs, 34% ($86 million) are savings to commercial payers, and 48% ($123 million) are savings for Medicare. Some legislation requires the pharmacist to explain the cost or price of the biologic and the interchangeable biosimilar. For example, the enacted laws in Colorado, Georgia, Illinois, North Carolina and Texas require that any authorized or allowable substitution must have the lowest cost. Yet the impact of uncertain factors, including price, uptake, and financing policies could also affect the cost of using biosimilars.