Below is an excerpt from an article by AlignRx chief pharmacy officer Beckie Fenrick and Goodroot area vice president of business development Brian Shonat that was recently published in BenefitsPRO.
Following decades of patent litigation and maneuvering, the first biosimilar to Humira is now available with many more to follow this year. Humira is a popular biologic drug used to treat inflammatory diseases such as rheumatoid arthritis and psoriasis. It’s the world’s all-time top-selling drug in terms of revenue, with an average annual cost of about $80,000 per patient. Employers, brokers and TPAs are all wondering, how will Humira biosimilars impact healthcare costs?
There has been a lot of buzz over anticipated cost savings from biosimilars. However, those savings may be realized more gradually than many expect. Employers, brokers and TPAs need to calibrate their expectations for how Humira biosimilars will impact the cost of prescription drugs for groups and members as part of a comprehensive cost-containment strategy.
What are biosimilars?
Biosimilars are biological products that are highly similar to an existing FDA-approved biologic, often referred to as the reference product, like Humira. Prior to FDA approval as a biosimilar, a biologic product must demonstrate there are no clinical meaningful differences to the reference product.
Though frequently confused, biosimilars are not the same as generics. Biologics are large, complex molecules made from living sources such as bacteria, yeast or animal cells. Traditional drugs are molecules with more simple structures than biologics. Generics for traditional drugs are chemical compounds that can be reliably and identically reproduced as soon as a brand-name drug’s patent expires — they are essentially exact copies of a chemical compound.
Biosimilars are approved through a different pathway than generics. Some people might call them “bio-generics,” but in fact they will always be brand-name products. That doesn’t mean they won’t create savings in the long term, though, because they still introduce competition.
Not all biosimilars are designated by the FDA as interchangeable, but those that are, depending on state laws, may be substituted for the reference product without the prescriber having to change the prescription. Even without the interchangeable designation, which requires additional layers of study and testing, the clinical safety and effectiveness of biosimilars are highly similar to the reference product.