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Biosimilar considerations for patients

Key takeaways:

  • You likely have questions about what biosimilars are and how they work — you’re not alone1
  • To help biosimilars reach their full cost-saving potential, patients need to have
    these questions answered
  • Patients should know:

Biosimilars are as safe and effective as the originator biologic2

They are thoroughly evaluated by the FDA2

They can provide more treatment options—and potentially lower costs2

Greater affordability means greater access for the patients who need these treatments.3 But the usage of biosimilars is in large part dependent on patient and provider understanding. If you don’t understand what biosimilars are or what makes them as safe and effective as their originators, you might be less likely to use them.1 For that reason, it’s critical that patients understand how these drugs are made, how they get approved, and how they can generate cost savings. (To learn more about these topics, visit our Understanding Biosimilars page).

Patients could also be influenced by the coverage of a biosimilar through insurance and any out-of-pocket costs they may be responsible for. Provider recommendations will impact patients’ opinions of biosimilars, too.1

Here’s what you should know about biosimilars:

  • Biosimilars are as safe and effective as the originator biologic.
    • Biosimilars provide comparable treatment benefits and risks as the originator biologic drugs they are based on, and they are generally made using the same natural resources as the biologic drugs.2
  • Biosimilars are thoroughly evaluated by the FDA.
    • Before approving a biosimilar, FDA experts must conclude it is highly similar to—and has no clinically meaningful differences from—the original biologic. The FDA’s evaluation process ensures that all biosimilar products meet the FDA’s high standards for approval.2
    • Comparative clinical testing is part of the biosimilar development program. These studies contain the criteria that demonstrate that no clinically meaningful differences exist in terms of safety and efficacy between a biosimilar and its originator biologic.4
  • Biosimilars can provide patients with more options—and potentially lower costs.
    • The biosimilars that have entered the U.S. market have launched with initial list prices anywhere from 15% to 35% lower than their biologic competitors.5
    • As biosimilars offer additional treatment options for patients, biologics manufacturers could be inclined to lower the cost of the originator biologics to compete, and this competition could ultimately result in more savings to patients and increased access.3

Learn more about the key considerations for biosimilars with each of the following groups.

Prescribers

Learn more

Payers

Learn more

Specialty Pharmacies

Learn more

To learn more about the promise of biosimilars, the impact they can create, and our work in this space, visit the following pages:

The Promise
of Biosimilars

Going Beyond Biosimilars

Understanding
Biosimilars

Our Commitment
to Biosimilars

1. Cohen H, McCabe D. The importance of countering biosimilar disparagement and misinformation. BioDrugs 2020;34(4):407-414.
2. Biosimilar and interchangeable biologics: More treatment choices. U.S. Food and Drug Administration. October 12, 2021. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
3. Biosimilars in the United States 2023-2027. IQVIA. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027. Published January 31, 2023.
4. Center for Drug Evaluation and Research. Biosimilars review and approval. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/review-and-approval. Published December 13, 2022.
5. Decreasing drug costs through generics and Biosimilars. National Conference of State Legislatures. https://www.ncsl.org/health/decreasing-drug-costs-through-generics-and-biosimilars. Published January 21, 2022.

IMPORTANT SAFETY INFORMATION

Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.

CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction and spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.

Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.

Androgen deprivation therapy may prolong the QT/QTc interval. Consider periodic monitoring of electrocardiograms and electrolytes.

Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

Monitor serum levels of testosterone following injection of CAMCEVI.

Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.

The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

INDICATION

CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

Click here for full Prescribing Information.

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