Key TakeawaysThe FDA approved Rezvoglar as the second interchangeable biosimilar insulin product.Pharmacists can swap branded insulin for Rezvoglar at the counter without prior authorization from a physician.FDA approval also allows pharmacies to exchange brand-name products for similar generic products to a patient without a physician’s approval, similar to when generic drugs are swapped for branded drugs.The Food and Drug Administration (FDA) approvedRezvoglar(insulin glargine-aglr), the second interchangeable biosimilar insulin product in the United States. LikeSemglee, which was approved last year, Rezvoglar can serve as an affordable substitute for the more costly Lantus.Rezvoglar is a long-acting insulin designed to manage blood sugar levels in adults and young patients withtype 1 diabetesand in adults withtype 2 diabetes.“This approval furthers the FDA’s longstanding commitment to support a competitive marketplace for insulin products,” the FDA wrote in a statement. “The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.”The FDA said patients with diabetes can receive either Semglee or Rezvoglar at the pharmacy as an alternative to Lantus.According toMichael D. Goldberg, MD, an associate professor of clinical medicine at New York Medical College, Rezvoglar was approved as a biosimilar to Lantus last year and then designated as interchangeable with Lantus in November.When a drug is categorized as “biosimilar” it indicates that the drug is highly similar to and has no meaningful difference in clinical effect or safety from an existing FDA-approved reference drug.When a drug is classified as “interchangeable,” the drug can be substituted for a reference drug at the pharmacy level, without requiring permission from the prescribing provider, Goldberg said. However, that policy could vary depending on a state’s pharmacy laws. This FDA approval may also allow patients to have easier access to generic insulin if the prescribed drug is not available.“In other words, if a provider prescribes Lantus for their patient, the patient’s pharmacy may choose to dispense Semglee or Rezvoglar instead, without any need to consult the provider, if this practice is allowed in that particular state,” Goldberg said.Low-Cost Biosimilar Is Set to Disrupt the Drug MarketWhat Does This FDA Approval Mean for the Cost of Insulin?According to the FDA, this approval is significant because it expands patient access to biosimilar and interchangeable insulin products. This decision can potentially lower the cost of diabetes treatment, according toEliud Sifonte, MD, an endocrinologist at NYU Langone Health.“In 2009, Congress passed theBPCI Actto create a shortened pathway for approval of products that are biosimilar to other FDA-approved medications,” Sifonte said. “The idea behind this is to create competition in the hopes of lowering the costs of medications.”While the exact cost for Rezvoglar has not been announced yet, Goldberg said biosimilar insulins tend to be less expensive than their reference drugs, like how generic medications are usually cheaper than their brand-name equivalent.“It is important to keep in mind that actual out-of-pocket costs for any medication depend on other factors as well, such as insurance formulary coverage, deductibles, and copayments,” Goldberg added.How Can You Get Rezvoglar?Rezvoglar is available as a 3 ml prefilled pen and is injected once daily, underneath the skin, according to the FDA.However, the drug’s dosing and administration should be individualized and based on the patient’s metabolic needs, blood sugar monitoring, glycemic control, type of diabetes, and prior insulin use.Your access to Rezvoglar depends on your health insurance coverage and prescription, but you can talk to your healthcare provider or pharmacist about different insulin options.“Some states permit the pharmacist to make the change automatically if a biosimilar is available and cheaper,” Sifonte said. “Other states require the prescribing physician’s approval.”What This Means For YouThe FDA approval of Rezvoglar as a second interchangeable insulin biosimilar to Lantus provides more treatment options to patients and may lower the costs for certain insulin products.
Key TakeawaysThe FDA approved Rezvoglar as the second interchangeable biosimilar insulin product.Pharmacists can swap branded insulin for Rezvoglar at the counter without prior authorization from a physician.FDA approval also allows pharmacies to exchange brand-name products for similar generic products to a patient without a physician’s approval, similar to when generic drugs are swapped for branded drugs.
Key Takeaways
The FDA approved Rezvoglar as the second interchangeable biosimilar insulin product.Pharmacists can swap branded insulin for Rezvoglar at the counter without prior authorization from a physician.FDA approval also allows pharmacies to exchange brand-name products for similar generic products to a patient without a physician’s approval, similar to when generic drugs are swapped for branded drugs.
The Food and Drug Administration (FDA) approvedRezvoglar(insulin glargine-aglr), the second interchangeable biosimilar insulin product in the United States. LikeSemglee, which was approved last year, Rezvoglar can serve as an affordable substitute for the more costly Lantus.
Rezvoglar is a long-acting insulin designed to manage blood sugar levels in adults and young patients withtype 1 diabetesand in adults withtype 2 diabetes.
“This approval furthers the FDA’s longstanding commitment to support a competitive marketplace for insulin products,” the FDA wrote in a statement. “The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.”
The FDA said patients with diabetes can receive either Semglee or Rezvoglar at the pharmacy as an alternative to Lantus.
According toMichael D. Goldberg, MD, an associate professor of clinical medicine at New York Medical College, Rezvoglar was approved as a biosimilar to Lantus last year and then designated as interchangeable with Lantus in November.
When a drug is categorized as “biosimilar” it indicates that the drug is highly similar to and has no meaningful difference in clinical effect or safety from an existing FDA-approved reference drug.
When a drug is classified as “interchangeable,” the drug can be substituted for a reference drug at the pharmacy level, without requiring permission from the prescribing provider, Goldberg said. However, that policy could vary depending on a state’s pharmacy laws. This FDA approval may also allow patients to have easier access to generic insulin if the prescribed drug is not available.
“In other words, if a provider prescribes Lantus for their patient, the patient’s pharmacy may choose to dispense Semglee or Rezvoglar instead, without any need to consult the provider, if this practice is allowed in that particular state,” Goldberg said.
Low-Cost Biosimilar Is Set to Disrupt the Drug Market
What Does This FDA Approval Mean for the Cost of Insulin?
According to the FDA, this approval is significant because it expands patient access to biosimilar and interchangeable insulin products. This decision can potentially lower the cost of diabetes treatment, according toEliud Sifonte, MD, an endocrinologist at NYU Langone Health.
“In 2009, Congress passed theBPCI Actto create a shortened pathway for approval of products that are biosimilar to other FDA-approved medications,” Sifonte said. “The idea behind this is to create competition in the hopes of lowering the costs of medications.”
While the exact cost for Rezvoglar has not been announced yet, Goldberg said biosimilar insulins tend to be less expensive than their reference drugs, like how generic medications are usually cheaper than their brand-name equivalent.
“It is important to keep in mind that actual out-of-pocket costs for any medication depend on other factors as well, such as insurance formulary coverage, deductibles, and copayments,” Goldberg added.
How Can You Get Rezvoglar?
Rezvoglar is available as a 3 ml prefilled pen and is injected once daily, underneath the skin, according to the FDA.However, the drug’s dosing and administration should be individualized and based on the patient’s metabolic needs, blood sugar monitoring, glycemic control, type of diabetes, and prior insulin use.
Your access to Rezvoglar depends on your health insurance coverage and prescription, but you can talk to your healthcare provider or pharmacist about different insulin options.
“Some states permit the pharmacist to make the change automatically if a biosimilar is available and cheaper,” Sifonte said. “Other states require the prescribing physician’s approval.”
What This Means For YouThe FDA approval of Rezvoglar as a second interchangeable insulin biosimilar to Lantus provides more treatment options to patients and may lower the costs for certain insulin products.
What This Means For You
The FDA approval of Rezvoglar as a second interchangeable insulin biosimilar to Lantus provides more treatment options to patients and may lower the costs for certain insulin products.
1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Rezvoglar: highlights of prescribing information.
1 Source
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Rezvoglar: highlights of prescribing information.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Food and Drug Administration.Rezvoglar: highlights of prescribing information.
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