October Generic Focus

FDA Approves Lucentis Biosimilar, Cimerli, for Commercial Launch

The FDA approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn), a biosimilar of Genentech’s Lucentis (ranibizumab injection). Developed by bioeq, the joint venture of Polpharma Biologics and Formycon, Coherus will launch Cimerli in 0.3-mg and 0.5-mg doses in the United States in October 2022.

Ranibizumab-eqrn will be used to treat all 5 indications for ranibizumab injection including age-related neovascular (wet) macular degeneration and other serious retinal diseases such as diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. "As the impact of serious retinal diseases continues to rise in the United States, it is critical that treatment options are efficacious and affordable. Advanced biosimilars to ranibizumab injection can change patients’ lives while also minimizing the financial impact of the cost of treatment on health care systems,” Michael Soldan, CEO of Polpharma Biologics Group, said in a statement.

Cimerli is a member of the antivascular endothelial growth factor therapy class of biologics. It works by inhibiting vascular endothelial growth factor that causes excessive blood vessels to form in the retina, leading to impaired vision.

“Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar, and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients’ lives,” Soldan said.

Reference

Levy S. FDA approves Bioeq’s Lucentis biosimilar. Drug Store News. August 9, 2022. Accessed August 10, 2022. https://drugstorenews.com/fda-approves-bioeqs-lucentis-biosimilar

Online Pharmacy Offers Imatinib for Leukemia

The Mark Cuban Cost Plus Drug Company is offering imatinib mesylate, used to treat leukemia and other cancers, at a price at least $2000 lower than what other pharmacies charge.¹ “The markup on potentially lifesaving drugs that [individuals] depend on is a problem that can’t be ignored,” Alex Oshmyansky, MD, PhD, CEO and founder of Cuban’s online pharmacy, said in a statement. “It is imperative that we take action and help expand access to these medications for those who need them most.”¹

The company will sidestep pharmacy benefit managers, which negotiate prices among drug manufacturers, employers, and health insurers.² Generic drugs are typically 80% to 85% cheaper than brand-name equivalents, according to the FDA, and Cuban said his company is trying to manufacture its own generic drugs.²

A September 2021 poll from Gallup and West Health estimated that 10 million Americans could not afford 1 or more doctor-prescribed medications.

The Mark Cuban Cost Plus Drug Company will negotiate prices with the drug manufacturers directly¹ and offers more than 800 generic drugs to treat many diseases, such as cancer, diabetes, and heart conditions.

References

1. Hernandez J. Billionaire Mark Cuban launches online pharmacy aimed at lowering generic drug prices. NPR. January 24, 2022. Accessed August 10, 2022. https://www.npr.org/2022/01/24/1075344246/mark-cuban-pharmacy

2. Constantino AK. Mark Cuban’s pharmacy startup is actually making drugs less expensive. It’s still working on solving the real problem. CNBC. Updated August 23, 2022. Accessed September 12, 2022. https://www.cnbc.com/2022/07/28/mark-cuban-pharmacy-cost-plus-drugs-struggling-with-brand-name-drugs.html

Long Grove Pharmaceuticals Introduces Drug to Treat Multiple Types of Arthritis

Long Grove Pharmaceuticals’ FDA-approved triamcino-lone acetonide injectable suspension, USP, is now available to treat several types of arthritis and other intramuscular and intra-articular conditions.¹ This single-dose and multidose suspension is an AB-rated generic for Bristol Myers Squibb’s Kenalog-40. It is Trade Agreements Act–compliant and made in the European Union.¹

Established in 2019, Long Grove Pharmaceuticals of Rosemont, Illinois, focuses on complex generics, such as injectables and topical products. The new triamcinolone acetonide injectable suspension, USP, is the first in a yearlong series of launches from Long Grove.¹

Triamcinolone acetonide injectable suspension, USP, is a synthetic glucocorticoid corticosteroid anti-inflammatory.² Study results have shown that single 60-mg to 100-mg doses can cause adrenal suppression that returns to normal, according to the FDA.² The recommended dose is 60 mg in the gluteal musicle.

“We are excited about the launch of triamcinolone acetonide,” Dan Robins, PhD, president and CEO of Long Grove, said in a statement. “This successful launch required hard work from the entire team here at Long Grove. We are proud of this significant accomplish-ment and look forward to further expandingour portfolio.”

References

1. Long Grove Pharmaceuticals Launches Triamcinolone Acetonide Injectable Suspension, USP. Pharmacy Practice News. July 19, 2022. Accessed August 11, 2022. https://www.pharmacypracticenews.com/Industry-News/Article/07-22/Long-Grove-Pharmaceuticals-Launches-Triamcinolone-Acetonide-Injectable-Suspension-USP/67557

2. Triamcinolone acetonide suspension. FDA.report. 2022. Accessed August 11, 2022. https://fda.report/DailyMed/9e48eec7-7cd5-4174-8b3f-07c96f4ef115

Brand, Generic Amphetamine/Dextroamphetamin Face Shortages in Drug Stores

Amphetamine/dextroamphetamin, the generic form of Adderall, a popular stimulant prescribed for attention-deficit/hyperactivity disorder, is facing a potential shortage in the supply chain, which may not ease in US markets until October 2022, according to an article on the BestLife website. Drug shortages commonly occur, because of delays, discontinuation, or manufacturing issues, according to the article.

The COVID-19 pandemic exacerbated many supply chain issues. Although amphetamine/dextroamphetamin is not on the FDA’s shortage list yet, that could occur if the supply chain does not normalize, according to the article.

Brand-name and generic forms of Adderall were prescribed to almost 41 million individuals in 2021, according to the article.

Reference

Reinhard A. This common daily medication may become harder to find, makers say. BestLife. August 5, 2022. Accessed Aug 11, 2022. https://bestlifeonline.com/adderall-shortage-news/