Biosimilar to Eylea Approved, But Not Launched
On June 28, 2024, the U.S. Food and Drug Administration (FDA) approved Ahzantive™ (aflibercept-mrbb – Formycon AG/Klinge Biopharma) injection, a biosimilar for Eylea® (aflibercept – Regeneron) injection, 2mg. It is indicated to treat the same main conditions as Eylea – neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema after retinal vein occlusion (RVO). Eylea also is approved to treat 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. No information is available for pricing for the biosimilar. In May 2024, the FDA approved two additional biosimilars to Eylea, Opuviz™ (aflibercept-yszy – Samsung Bioepis/Biogen) injection and Yesafili™ (aflibercept-jbvf – Biocon Biologics) injection. The launch dates for all 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. Express Scripts is currently investigating the data around Ahzantive for a possible utilization management strategy. Here is the full prescribing information for Ahzantive.
FDA Approves Sandoz’ Biosimilar to Stelara
Sandoz received FDA approval on June 28, 2024, for Pyzchiva® (ustekinumab-ttwe), a biosimilar to Janssen’s Stelara®. By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation. Pyzchiva is indicated to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC). In addition, it’s also approved for patients as young as six years old who have psoriatic arthritis (PsA) or plaque psoriasis that is amenable to phototherapy or systemic therapy. Doses are based on the patient’s weight. For psoriatic conditions, two initial subcutaneous (SC) doses are given one month apart, and then treatment switches to one SC injection every three months. Patients who have CD or UC receive one intravenous (IV) infusion followed by SC injections at two-month intervals. Pyzchiva will be available as 45mg/0.5mL and 90mg/mL single-dose prefilled syringes for SC injection and 30mg/26mL (5mg/mL) single-dose vials for IV infusion. Patients who use ustekinumab may be more susceptible to acquiring infections, including tuberculosis (TB), and of developing cancer. Sandoz will market Pyzchiva in the U.S. under a settlement agreement that allows its release for sale in February 2025. Several biosimilars to Stelara are expected to launch early next year, including FDA-approved Wezlana™ (ustekinumab-auub – Amgen) and Selarsdi™ (ustekinumab-aekn – Alvotech/Teva). For Pyzchiva’s prescribing information, click here.
New Neupogen Biosimilar Approved
Tanvex BioPharma received FDA approval for Nypozi™ (filgrastim-txid) on June 28, 2024. A biosimilar for Amgen’s Neupogen®, it is a colony-stimulating factor (CSF) that promotes the production of neutrophils, a key component of the immune system. Nypozi’s indications are to decrease infection risk for patients who are undergoing myelosuppressive chemotherapy (chemo) for non-myeloid cancer, to accelerate neutrophil recovery for patients receiving induction or consolidation chemo for acute myeloid leukemia (AML), to shorten the length of neutropenia for patients having bone marrow transplants and to mitigate their conditions for patients who have congenital, cyclic or idiopathic neutropenia. It is also used during the collection of hematopoietic progenitor cells and in patients exposed to high doses of radiation. Doses, which differ according to the condition being treated, may be injected IV or SC. It will be available in single-dose prefilled syringes containing either 300mcg/0.5mL or 480mcg/0.8mL. The launch plans are not known at this time. Three other Neupogen biosimilars, Zarxio™ (filgrastim-sndz – Sandoz), Nivestym™ (filgrastim-aafi – Pfizer), and Releuko (filgrastim-ayow – Amneal/Kashiv Biosciences) are currently available on the market. For the 12 months ending March 2024, IQVIA estimates that U.S. sales for all filgrastim products amounted to $403 million. For full prescribing information, look here.