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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 6 | Issue 11
June 1, 2024

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First Interchangeable Biosimilars for Eylea

On May 20, 2024, the U.S. Food and Drug Administration (FDA) approved Yesafili™ (aflibercept-jbvf) and Opuviz™ (aflibercept-yszy) as interchangeable biosimilars for Eylea® (aflibercept). Both biosimilars are approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic neuropathy. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor that works by preventing unusual blood vessel growth in the eye. Through this blockage of VEGF, aflibercept reduces damage to the retina and helps preserve vision. Depending on the state pharmacy laws, interchangeable biosimilars may be substituted for the reference product without requiring prescriber consultation. Comparative data demonstrated that both products showed a high similarity to Eylea® and had no clinically meaningful differences in safety and effectiveness. Side effects seen with Yesafili™ and Opuviz™ are similar to Eylea®, including eye pain, cataract, broken blood vessels in the eye, floaters and increased eye pressure. The approval of Yesafili™ and Opuviz™ will increase accessibility of this treatment at a potentially lower cost. The exact timeframe when Yesafili™ and Opuviz™ will become available is still unknown due to ongoing litigation.

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Drug Safety

FDA Issues a Warning Letter to Cue Health for their COVID-19 Tests

On May 9, 2024, Cue Health, Inc. received a warning letter from the FDA regarding COVID-19 tests. Cue Health was authorized to produce COVID-19 tests under the emergency use authorizations (EUAs) in August of 2020 and March of 2021. Upon recent inspection, the FDA found that Cue Health made several changes to COVID-19 testing devices without authorization from the FDA. The changes made to Cue Health’s COVID-19 tests have reduced their reliability and increased their potential for false results. The FDA is warning consumers and patient care settings to stop using Cue Health’s COVID-19 tests due to increased risk of false results. It is recommended that consumers dispose of those COVID-19 tests and consider retesting using a different, FDA-authorized, test. If any problem arises when using Cue Health’s COVID-19 tests, you are requested to report the instance through the MedWatch Voluntary Reporting Form

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From the Pharmaceutical Industry

DEA Plans to Reclassify Marijuana from a Schedule I to a Schedule III Controlled Substance

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act.

Schedule I drugs have a high potential for abuse and are not permitted for medical use. Schedule III drugs have a lower potential for abuse and have accepted medical applications. There is supportive evidence for using marijuana to treat chronic pain, nausea and vomiting in cancer patients and certain neurological conditions. However, marijuana can also adversely affect one’s mental health. Multiple studies have suggested that heavy marijuana users are more likely to report suicidal ideations than non-users. After evaluation of various epidemiological databases, the federal health review concluded the risks of using marijuana are lower compared to other drugs of abuse, such as heroin or cocaine.

The DEA’s proposal was followed by the May 16, 2024 notice of proposed rulemaking submission to the Federal Register which starts the process of moving marijuana from Schedule I to Schedule III under the Controlled Substances Act.  With this notice in place, the DEA will now gather and review comments and information submitted by the public prior to making a final determination at a future date.

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FDA Approvals

New FDA Approvals

New Drug: Myhibbin® (mycophenolate mofetil) 

Oral capsules indicated for the treatment of patients 12 years and older with WHIM (warts, hypogammaglobulinemia, infections, myelokathexis) syndrome, a rare genetic disease of the immune system in which white blood cells are trapped in the bone marrow. [4/26/24 - X4 PHARMACEUTICALS INC]

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New Generics

New Generics Entering the Marketplace

Halaven® (eribulin mesylate)

Indication: Treatment of metastatic (spread to other parts of the body) breast cancer in patients who have received at least two other cancer treatment regimens and for the treatment of unremovable or metastatic fatty tissue cancer (liposarcoma) in patients who have received a prior cancer treatment. 

Dosage Form/Strength: 1mg/2ml IV Injection

Average Wholesale Price (AWP): Generic = $804 | Brand = $846