Generic medications play an important role in healthcare cost savings.\u00a0 For FDA approval, a generic drug must be identical in strength, dosage form, and route of administration and be bioequivalent.\u00a0 In other words, the generic drug for all intents and purposes must be the same as the brand reference drug.\u00a0 A biosimilar, on the other hand is approved if it shows that it is highly similar to an FDA-approved biologic product known as a reference product.\u00a0 In addition, a biosimilar is not labeled as bioequivalent to the reference drug.\u00a0 Thus, unlike a generic medication, a biosimilar is not interchangeable with the reference drug without the prescriber\u2019s approval.<\/p>\n
So how does a biosimilar fit into the healthcare spending equation?\u00a0 Biosimilar are expected to be 15-30% less expensive than the originator drugs.\u00a0 However, to benefit fully from this potential cost savings, the biosimilar needs to be interchangeable with its reference drug.\u00a0\u00a0 The ability to interchange a biosimilar with its reference drug allows the pharmacist to dispense a biosimilar when the prescription is written for the reference drug, much similar to how generics are dispensed for brand name products.\u00a0 If a biosimilar is not interchangeable with its reference drug, it will certainly not be as readily dispensed since each request to change to a biosimilar will require the prescriber\u2019s approval.<\/p>\n
Currently, there are 2 biosimilars approved in the United States.\u00a0 Zarxio, a biosimilar version of filgrastim and Inflextra, a biosimilar to Remicade.\u00a0 Biosimilar for a few other blockbuster drugs such as Enbrel and Humira are expected to be approved by the FDA later this year.\u00a0 Experts believe biosimilars will lead to a $40 billion dollars savings over the next 10 years.\u00a0 To see this savings, doctors, patients, payors, and legislators will need to have a better understanding of biosimilars and how best to expand its access to patients.\u00a0 With the skyrocketing cost of biologic medications, biosimilars may be our knight in shining armor to rescue us from this specialty drug distress.<\/p>\n
Submitted by Stan Leung PharmD, PHC Director of Pharmcy<\/p>\n
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Generic medications play an important role in healthcare cost savings.\u00a0 For FDA approval, a generic drug must be identical in strength, dosage form, and route of administration and be bioequivalent.\u00a0 In other words, the generic drug for all intents and … Continue reading