Kristine Kucera, PA-C, MPAS, DHS
Preparing for the Launch of Biosimilars
Biologic therapies have revolutionized the way that we treat autoimmune diseases in our daily practice. The term biologic is defined as an approved product composed of proteins, nucleic acids, or living entities, such as cells and tissues, that is isolated from natural sources and produced by biotechnology methods. In 2009, the Biologics Price Competition and Innovation Act was passed. It created the opportunity for the development of biosimilars. A biosimilar is a biologic medication developed in a way that there are no clinically meaningful differences between the biologic product and the original product in terms of safety, purity, and potency. Biosimilars are made with the same types of living sources, are given to the patient in the same way, and have the same strength, dosage, potential treatment benefits, and potential side effects as the reference product.
The first biosimilar was approved by the FDA in 2015, and beginning in 2016 several biosimilars have been approved with indications for psoriasis and psoriatic arthritis. Biosimilars hold the promise of substantial cost savings for patients living with psoriatic disease. However, a biosimilar is not considered a “generic” in the same way that a traditional drug is a generic. Biologics generally cannot be copied exactly, because the products usually contain a mix of many slight variations of a protein, and this mix is never exactly the same in each dose or batch of the product. However, an important fact is the FDA has stated it will allow a pharmacist to automatically substitute a biosimilar for the reference brand if the product has been deemed interchangeable. If the product has been determined to be interchangeable, then it is expected to produce the same clinical result as the reference product in any given patient without a risk of diminished efficacy or safety. Pharmacists will be responsible for knowing which biological products are interchangeable and can check The Purple Book to find these products.
Recently, the National Psoriasis Foundation Medical Board released a position statement on the use of biosimilars for psoriasis and psoriatic arthritis. The board’s position is as follows:
- We consider biosimilars to be similar to the reference product in the treatment of psoriasis and psoriatic arthritis,
- We recognize the interchangeability of biosimilars with the additional regulatory designation of “interchangeability” and concur with substitution of reference products for biosimilars where appropriate, and
- A loss in efficacy or tolerability to a reference product or its biosimilar product may warrant switching to a different medication, rather than to another biosimilar of the reference product.
As biosimilars come to market over the next several months, prescribers and patients should be aware of potential substitution. Whether patients are newly prescribed a biologic or have been treated with one for many years, they are likely to contact your practice if the brand they receive from the pharmacy is not the one they expected.
DID YOU KNOW?
- The four letters following the molecular name distinguish the branded biologics from biosimilars.
- FDA describes the Purple Book as a searchable online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
Kristine Kucera, PA-C, MPAS, DHS, is Assistant Clinical Professor, University of Texas Southwestern, Medical Center PA Program, Dallas, TX. She is a member of the DEF Advisory Council.
National Psoriasis Foundation Position Statement on Biosimilars
The Language of Biosimilars: Clarification, Definitions and Regulatory Aspects
Biosimilars: Overview for Heath Care Professionals
What are Biosimilars? Top Facts You May Not Know
The Purple Book