Another Biosimilar to Eylea Approved, But Not Launched

On Aug. 9, 2024, the U.S. Food and Drug Administration (FDA) approved Enzeevu^™ (aflibercept-abzv – Sandoz) injection, a biosimilar to Eylea^® (aflibercept – Regeneron) injection, 2mg. Enzeevu is indicated to treat neovascular age-related macular degeneration (nAMD). Eylea is approved to treat nAMD and four additional indications including macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and retinopathy of prematurity (ROP). Aflibercept 2mg is injected intravitreally by an ophthalmic specialist in a sterile setting – usually once every month or once every two months. After one year of treatment, some patients may receive injections once every three months, although it’s not as effective as the once every two months dosing regimen. Enzeevu is the fourth biosimilar to Eylea, and it has been approved by the FDA. Others include Opuviz^™ (aflibercept-yszy – Samsung Bioepis/Biogen), Yesafili^™ (aflibercept-jbvf – Biocon Biologics) and Ahzantive^™ (aflibercept-mrbb – Formycon AG/Klinge Biopharma). The launch dates for all four Eylea biosimilars remain undetermined due to continuing patent lawsuits. In August 2023, Regeneron introduced an 8mg strength, Eylea^® HD injection, which can be given once every two months or every four months. This new formulation is patent-protected until at least 2039. For 2023, U.S. sales of Eylea amounted to approximately $5.9 billion, including about $166 million from the 8mg strength, according to Regeneron. Here is its full prescribing information.

Expanded Heart Failure Indication Approved for Furoscix

On Aug. 9, 2024, the FDA approved an expanded heart failure indication for scPharmaceuticals’ Furoscix^® (furosemide). In October 2022, Furoscix was approved to treat congestion due to fluid overload associated with New York Heart Association (NYHA) Class II or Class III chronic heart failure in adults. Now, it can also be used in adults with NYHA Class IV chronic heart failure; therefore, all adults with chronic heart failure are candidates for treatment. Class IV is the most advanced stage and patients may experience discomfort even at rest or with minimal physical activity. Furoscix is a loop diuretic that is packaged in single-dose cartridges that fits into a one-use infusion device that adheres to the skin of the abdomen. It allows for subcutaneous (SC) self-administration of the medication. Each cartridge of Furoscix releases 30mg of furosemide over one hour, followed by 12.5mg/hr for the next four hours, providing a total dose of 80mg. Patients should not bend or move excessively while wearing the device, and they should not use it while sitting in a vehicle. The device should not get wet. It should not be activated within 12 inches of an electronic device, such as a cellphone or computer. Furoscix is not for emergency use, for patients who have acute pulmonary edema, or for long-term administration. Patients should be transitioned to an oral form of furosemide as soon as possible. Updated prescribing information can be found here.

Additional Approval for Imfinzi

Astra Zeneca’s Imfinzi^® (durvalumab) injection received a new indication from the FDA on August 15, 2024. It now can be used with platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinzi as adjuvant treatment after surgery, for adult patients with resectable non–small cell lung cancer (NSCLC) that is ≥4cm in size and/or node-positive, and who do not have known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement. The approval was based on the AEGEAN study in which treated patients had a median event-free survival that was not reached versus 25.9 months for placebo. A complete response (CR) was also observed in 17% of treated patients versus 4.3% in the placebo group. For the new indication, Imfinzi, a programmed death-ligand 1 (PD-L1) blocking immunotherapy, will be administered by intravenous (IV) infusion at a dosage of 1,500mg every three weeks as neoadjuvant therapy and every four weeks as adjuvant therapy for patients weighing 30kg or more. For patients weighing less than 30kg, the dosage will be 20mg/kg. Imfinzi should be given before chemotherapy if both are administered on the same day. Imfinzi has previous indications for treating adults who have other types of NSCLC, extensive-stage small cell lung cancer (SCLC), or biliary tract cancer. Together, Imfinzi and Imjudo®(tremelimumab-actl) injections are approved to treat unresectable hepatocellular carcinoma (HCC) and NSCLC without EGFR, ALK, or ROS1 mutations. They are used along with chemo which includes a platinum-containing drug. It is also used to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Today Imfinzi also received an FDA Priority Review for patients with limited-stage SCLC with a decision expected in the fourth quarter of 2024. For full prescribing details, click here.