National Psoriasis Foundation Biosimilar Statement: Frequently Asked Questions
What are biosimilars? Are they generic versions of biologics?
Biologic drugs, or biologics, are protein-based drugs derived from living cells cultured in a laboratory. They are given by injection or intravenous (IV) infusion and target specific parts of the immune system. Biosimilars are treatments that are very similar to an already approved biologic drug. However, biosimilars are not generic versions of biologics because there's no way to precisely copy a drug made from living cells.
Why did the National Psoriasis Foundation develop a biosimilar position statement?
National Psoriasis Foundation (NPF) believes the doctor-patient relationship should be at the center of all treatment decisions for psoriasis and psoriatic arthritis. The NPF Medical Board developed the biosimilar statement to guide health insurance companies, government agencies, lawmakers, the pharmaceutical industry and the patient community. As we encourage the development of new, safe and effective treatment options, we want to ensure that the treatment decisions remain between doctors and patients, not the pharmacy.
What are the key provisions of the statement?
To keep the patient-provider relationship at the center of all treatment planning, the statement acknowledges that:
- the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
- the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
- the biosimilar product follows the same route of administration and dosage form as the reference product;
- the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute within 48 hours of the substitution;
- the prescribing physician has not indicated the patient must be treated with the prescribed biologic (via instruction to the pharmacist to dispense as written);
- the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
- upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record inthe patient's medical record of the biosimilar substitution.
Could a pharmacist switch my medication from what my physician prescribed?
Substitutions may be made by pharmacists or health insurance companies under some circumstances without consulting you or your doctor. While biologic products are regulated by the federal government, each state has its own laws to regulate drug and biologic substitution.
Biosimilars sound like a promising new treatment option for my psoriasis and psoriatic arthritis, do you agree?
NPF welcomes new treatment options that will have a positive impact for patients. It's anticipated that biosimilars may bring drug costs down. We encourage the development of biosimilars, but want to be sure that insurers and other payers do not have the final word on who receives biosimilars versus biologics, especially in cases where the prescribed biologic might be the more appropriate treatment.
How do I know the NPF has not just developed this position to please industry partners?
The NPF works to dramatically improve the health of individuals living with psoriatic disease. We are eager and willing to partner with any organization or entity that shares a commitment to that mission. NPF works closely and productively with a broad range of health care stakeholders including health insurance companies, medical societies, pharmacy benefit managers, pharmaceutical firms, and health care professionals to help improve the lives of psoriatic disease patients. We firmly believe that co-operation between all health care stakeholders is key to achieving our goals and we take our role as representatives of patients very seriously and we are aware of, and vigilant about, potential conflicts of interest.
What is the National Psoriasis Foundation doing to address the burden of high out-of-pocket costs?
NPF works to make treatments affordable and accessible to patients through several efforts. We educate individuals and providers about treatment assistance programs that can reduce the costs of these medications through our Navigation Center. These programs and resources often significantly reduce the out-of-pocket costs for treatments. We also actively engage policymakers at the state and federal level to encourage solutions be implemented to improve access to therapies. At the federal level, we urge congress to support access to care with the Patients' Access to Treatments Act (PATA). PATA would protect access to vital treatments by lowering out-of-pocket costs for specialty drugs, such as biologics, in commercial health plans. Learn more about this legislation » At the state level, we work in coalition to advance legislation and regulatory reform which would address high co-insurances and out of pocket costs. Furthermore we encourage states to adopt legislation that would encourage insurers to offer plans with more affordable co-pays across an entire formulary.