Biosimilars in Psoriasis: The Future or Not?
As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed “highly similar” to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimilars are not the same as small-molecule generics because they have a complex manufacturing process that makes it impossible to produce identical products to their reference products. Therefore, should biosimilars be granted FDA approval for the same indications as their reference products? Furthermore, can biosimilars automatically be substituted for the branded drug at the pharmacy level? Putting aside these technical concerns, physicians must focus on the impact of biosimilars on patient care. These agents will have to be integrated into a complex health care system comprised of drug developers, employers, payers, and drug formularies.
Practice Points
- Three biosimilars have been approved by the US Food and Drug Administration to treat adult patients with plaque psoriasis and psoriatic arthritis.
- By virtue of their production, biosimilars are not identical to their reference products, and we must ensure that their safety is comparable.
Economic Advantages of Biosimilars
The annual economic burden of psoriasis in the United States is substantial, with estimates between $35.2 billion22 and $112 billion.23 Biosimilars can be 25% to 30% cheaper than their reference products9,11,24 and have the potential to save the US health care system billions of dollars.25 Furthermore, the developers of biosimilars could offer patient assistance programs.11 That being said, drug developers can extend patents for their branded drugs; for instance, 2 patents for Enbrel (Amgen Inc) could protect the drug until 2029.26,27
Although cost is an important factor in deciding which medications to prescribe for patients, it should never take precedence over safety and efficacy. Manufacturers can develop new drugs with greater efficacy, fewer side effects, or more convenient dosing schedules,26,27 or they could offer co-payment assistance programs.26,28 Physicians also must consider how the biosimilars will be integrated into drug formularies. Would patients be required to use a biosimilar before a branded drug?11,29 Will patients already taking a branded drug be grandfathered in?11 Would they have to pay a premium to continue taking their drug? And finally, could changes in formularies and employer-payer relationships destabilize patient regimens?30
Conclusion
Preliminary results suggest that biosimilars can have similar safety, efficacy, and immunogenicity data compared to their reference products.19,21 Biosimilars have the potential to greatly reduce the cost burden associated with psoriasis. However, how similar is “highly similar”? Although cost is an important consideration in selecting drug therapies, the reason for using a biosimilar should never be based on cost alone.
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