Key takeaways:
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).
Learn more about the key considerations for biosimilars with each of the following groups.
To learn more about the promise of biosimilars, the impact they can create, and our work in this space, visit the following pages:
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.
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.
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
Click here for full Prescribing Information.
©2024 Accord BioPharma, Inc. All rights reserved WS-ABI-2200001
Cookie | Duration | Description |
---|---|---|
cookielawinfo-checkbox-analytics | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". |
cookielawinfo-checkbox-functional | 11 months | The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". |
cookielawinfo-checkbox-necessary | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". |
cookielawinfo-checkbox-others | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other." |
cookielawinfo-checkbox-performance | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". |
viewed_cookie_policy | 11 months | The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. |