New Humira Biosimilar Wins FDA Approval

Simlandi^® (adalimumab-ryvk) injection, 40mg/0.4mL, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 23, 2024. A biosimilar that is interchangeable with Humira’s higher-strength citrate-free version, it is indicated to treat adults who have ankylosing spondylitis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis (PsA) rheumatoid arthritis, ulcerative colitis (UC) and uveitis. It also has indications for treating Crohn’s disease for patients at least six years old and juvenile idiopathic arthritis (JIA) for patients at least two years old. The manufacturers, Alvotech and Teva Pharmaceuticals, plan an “imminent” launch with 12 months  of “interchangeable exclusivity” for the strength. In states that allow substitution, Simlandi can be dispensed instead of Humira without contacting the prescriber for permission to substitute. Until the exclusivity period ends, no other interchangeable biosimilars to Humira 40mg/0.4mL can be approved by FDA. However, non-interchangeable biosimilars to this strength can still be approved and marketed. It will be dispensed in single-dose self-injector devices and given by subcutaneous (SC) injections — usually once every two weeks. For many of its adult indications, the recommended maintenance doses are 40mg, after higher loading doses. Pediatric dosing is based on the child’s weight. Like all drugs that block the activity of tumor necrosis factor (TNF), Humira and its biosimilars must have boxed warnings outlining the increased chances that cancer and serious infections may be associated with their use. Prospective patients also should be screened for tuberculosis (TB) before starting treatment and periodically during therapy. Two other biosimilars, Boehringer Ingelheim’s Cyltezo^® (adalimumab-adbm) and Pfizer’s Abrilada^™ (adalimumab-afzb) have interchangeable status for different versions of Humira. Several other Humira biosimilars, including high concentrated formulations, are available in the U.S. Prescribing information for Simlandi is here.

New Long-Acting Lacosamide Launched

In a press release dated Feb. 26, 2024, Acuta Pharmaceuticals announced its U.S. release of Motpoly XR^™ (lacosamide) extended-release capsules, a bioequivalent to Vimpat^® (lacosamide) tablets. Used alone or along with other anti-seizure medications, it is indicated to treat partial onset seizures for patients who weigh 50kg (110 pounds) or more. Based on the patient’s age and response to treatment, recommended dosing ranges between 100mg and 400mg in one daily dose. Vimpat must be taken twice a day. Patients taking any lacosamide product should be watched for signs of depression or suicidal behaviors. Other side effects may include blurry vision, dizziness, fainting, headaches and nausea. Motpoly XR was approved by the FDA in May 2023. Here is its prescribing information.

Biktarvy Indication Extended

The indication for Gilead Sciences’ Biktarvy ^® (bictegravir/emtricitabine/tenofovir alafenamide), tablets was broadened by the FDA on Feb. 23, 2024. Also known as B/F/TAF or BIC/FTC/TAF, Biktarvy originally was FDA approved in 2018 as initial therapy or as therapy for previously treated adults who have fewer than 50 copies of HIV-1 RNA per mL of blood (virological suppression) after stable doses of another anti-HIV regimen for at least three months. Later, it gained approval for pediatric patients who weigh at least 14kg (about 31 pounds). Prospective patients must not have failed on prior treatment and they must not have shown resistance to any of the drugs that are contained in Biktarvy. Now, it also is indicated for patients who have resistance to other treatments due to M184V/I resistance mutations. Identified in as many as 63% of patients who have resistance to nucleoside reverse transcriptase inhibitors (NRTIs), M184V/I mutations promote resistance to some HIV medications but enhance the effects of others. Once resistance develops, it cannot be reversed. Taken once a day, Biktarvy contains an integrase strand transfer inhibitor (INSTI) and two NRTIs. In the study that led to the approval, all of the patients whose responses could be evaluated and who had previous M184V/I resistance to other treatments maintained virological suppression and none developed resistance to Biktarvy after 48 weeks of treatment with it. Biktarvy has a boxed warning for patients who have both HIV and hepatitis B (HBV) because HBV may re-emerge when treatment is stopped. Its revised prescribing information may be found here.

Pediatric Indication Expanded for Veklury

The age range for another Gilead product, Veklury^® (remdesivir) injection, was extended by the FDA on Feb. 28, 2024. Used for treating COVID-19, its once-daily intravenous (IV) infusions now can be given to babies, including newborns, who are younger than 28 days old and who weigh at least 1.5kg (3.3 pounds). It is a nucleotide analog that slows or prevents viral reproduction by interfering with the RNA of SARS-CoV-2 virus. Patients may be in the hospital or they may be outpatients who have mild or moderate COVID-19, but who are at increased risk for progressing to severe infection. Depending on whether or not the patient is hospitalized, treatment lasts between three days and 10 days. Treatment should begin no more than seven days after COVID-19 symptoms are evident. Veklury should be given in facilities that are equipped and staffed to provide emergency treatment for severe infusion reactions that may be associated with administering it. For patients weighing less than 40kg (88 pounds), only the powdered form of Veklury for reconstitution and dilution is approved: the concentrated ready-to-dilute solution form should not be given to children. After a double-strength loading dose on the first day, the recommended daily dose for pediatric patients is either 1.25mg/kg or 2.5mg/kg based on both age and weight. Here is the updated prescribing information.

New Dosage Form for Acthar Gel

Mallinckrodt received FDA approval on Feb. 29, 2024, for a self-injectable form of Acthar^® Gel (repository corticotropin injection). Administered either intramuscularly (IM) or SC , it is used as short-term treatment for a wide range of mostly autoimmune conditions as well as for nephrotic syndrome and infantile spasms. For adults, a main use is to manage acute multiple sclerosis (MS) attacks. Doses differ substantially according to the condition being treated, its severity, the patient’s plasma and urine corticosteroid levels and the patient’s response to therapy. Dosing frequency and duration also are quite variable, with most regimens lasting between two weeks and three weeks, usually followed by a period of gradually reduced dose sizes and/or lengthened time between doses to discontinue therapy. The use of Acthar Gel must be closely monitored because long-term use of 40 Units or more per day may result in permanent and potentially serious cardiovascular (CV), electrolyte, endocrine, gastrointestinal (GI), musculoskeletal, neurologic, ophthalmic and other problems. The new SelfJect^™ devices contain either 40 Units or 80 Units, which can be used only for complete SC doses, not injected partially. Their release is planned for the second half of 2024. Look here for current prescribing information.

Recall
On Feb. 26, 2024, Brassica Pharma voluntarily recalled Equate^® Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS^® Health Lubricant Eye Ointment and Lubricant PM Ointment with various lots and expiration dates. Lubricant eye ointment is meant to keep a moisture barrier on the eye to prevent problems like dryness, injury or infection. Lubricant eye ointments are intended to be sterile. The recall is being initiated because the ointment potentially lacks sterility which could put patients at risk for eye infections or harm. For more information on the recall, see here.