For the over 8 million Americans living with psoriasis, biosimilars offer a promising path to more affordable treatment. These medications, designed to closely mimic costly biologics like Humira, Enbrel, Remicade, and Stelara, can reduce costs by 15% to 30% or more, according to the FDA, with “no clinically meaningful differences” from their brand-name counterparts. Despite this potential, only 13 of the 21 FDA-approved biosimilars for psoriasis are currently available. Here’s a look at why these cost-saving alternatives face barriers and what patients need to know.
What Are Biosimilars?
Biosimilars are medications made from living cells, similar to biologics, and are introduced after the original biologic’s patent expires. They target the overactive immune system that drives psoriasis, a condition causing rapid skin cell growth and resulting in itchy, scaly patches that can burn or sting. Psoriasis is also linked to serious health issues like heart disease, diabetes, and depression. Treatment options include topicals, light therapy, nonsteroidal anti-inflammatory drugs, biologics, and biosimilars.
Why Aren’t More Biosimilars Available?
Several obstacles prevent biosimilars from reaching patients:
- Insurance Preferences for Brand-Name Biologics
Health insurers often prioritize biologics on their formularies (lists of covered drugs) due to larger rebates negotiated with biologic manufacturers, according to Kavita Y. Sarin, MD, PhD, a dermatology professor at Stanford Medicine. This can make it harder for biosimilars to compete. - Step Therapy Requirements
Many insurance plans enforce “step therapy,” requiring patients to try and fail other treatments, including biologics, before approving a biosimilar, even if the patient has tried those treatments before. - Patent Disputes
Legal battles over drug patents can delay biosimilar launches by years. For example, Adalimumab (Amgevita), approved in 2016, wasn’t available until January 2023. Sarin notes that the median time from FDA approval to market availability for adalimumab biosimilars is just over a year. - Limited Patient Awareness
An American Academy of Dermatology survey found that over 70% of psoriasis patients have a poor understanding of biosimilars, which may contribute to hesitation in using them. - Manufacturer Incentives
Some biosimilar makers are subsidiaries of the companies producing original biologics, potentially creating incentives to delay competition. While unproven, some launches have been delayed after confidential settlements with originator companies. A proposed Senate bill, the Preserve Access to Affordable Generics and Biosimilars Act (S. 142), aims to prohibit such agreements but has not yet passed.
How Effective Are Biosimilars?
Research shows biosimilars are generally as safe and effective as biologics for psoriasis. Duc Binh Phan, MSc, a research associate at the University of Manchester, reviewed 16 studies on biosimilars for adalimumab, etanercept, and infliximab, finding comparable effectiveness and safety. However, one study noted a slightly higher risk of adverse events with an adalimumab biosimilar, highlighting the need for further research.
Patients switching from biologics to biosimilars may experience mild side effects or injection-site reactions, possibly due to differences in injection devices or psychological factors like the “nocebo effect” (expecting a treatment to be less effective). Phan advises tailoring treatments to individual patients and notes that some may develop immunity to biologics over time, requiring a switch to a different drug.
Cost Savings and Challenges
Biosimilars can significantly reduce costs. For example, a Humira pen costs around $3,650 without insurance, while a biosimilar version is listed online for about $674. However, patients may not always see these savings, as insurers or pharmacy benefit managers (PBMs) may retain the cost difference, depending on the plan.
Additionally, patients may face unexpected switches between biosimilars or back to biologics due to changes in insurance coverage. Melissa C. Leeolou, a fourth-year medical student at Stanford and psoriasis patient, notes that such substitutions can occur without notifying the patient or their doctor, especially if a biosimilar is deemed interchangeable by the FDA.
What Patients Can Do
- Educate Yourself: Learn about biosimilars and discuss them with your doctor to understand if they’re a good fit for your treatment plan.
- Monitor Prescription Changes: If your medication changes unexpectedly, contact your doctor. They can investigate the reason and, if needed, request prior authorization or file an appeal with your insurer.
- Request Specific Prescriptions: Ask your doctor to mark prescriptions as “dispense as written” to reduce the chance of substitutions, though this may not override insurer policies.
- Stay Informed: Follow updates on biosimilars and advocate for policies like the Preserve Access to Affordable Generics and Biosimilars Act to improve access.
A Path Forward
Biosimilars hold immense promise for making psoriasis treatment more affordable, but barriers like insurance policies, legal delays, and low awareness continue to limit access. By staying informed and working closely with healthcare providers, patients can better navigate these challenges and access the treatments they need.