Currently 90% of all prescriptions dispensed in the United States are for generic drugs, according to the annual report from the Office of Generic Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration. In 2021, the generic drug program approved hundreds of abbreviated new drug applications.
Following closely on the heels of FDA approvals, generic drug companies have launched a slew of generics, as well as biosimilars, in a broad range of therapeutic categories that include dermatology, oncology, antibiotics, ophthalmology and more. Here’s a look at the latest exciting introductions in the generic drug categories.
Accord Healthcare has added carmustine to its line of chemotherapy drugs. The drug is formulated as a sterile lyophilized (freeze-dried) powder to be reconstituted for intravenous infusion.
Carmustine is the generic of Avet Pharmaceuticals’ BiCNU and is approved for use in the treatment of certain types of brain tumors and blood cancers.
Accord is offering carmustine in a 50-mg size, as well as the new, larger 300-mg strength, which was not previously available in the market and overcomes the potential need to use multiple vials of the smaller size, the company said.
“We are proud to be able to provide carmustine lyo. injection in a unique dosage size that is not currently available in the market,” said Kevin Congdon, Accord’s vice president of institutional sales. “Adding this chemotherapy drug to our portfolio illustrates Accord’s commitment in the U.S. market to support healthcare providers in prescribing accessible oncology medications.”
Carmustine lyo. injection is used alone or with other drugs to treat glioblastoma, astrocytoma, medulloblastoma and other types of malignant brain tumors; relapsed or refractory Hodgkin’s lymphoma; multiple myeloma, a blood cancer that affects the bone marrow; and relapsed or refractory non-Hodgkin lymphoma (the disease has recurred or has not gotten better with other treatment).
Coherus BioSciences is offering Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Roche’s Lucentis (ranibizumab injection) for all approved indications.
An anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision, Cimerli was approved by the FDA in August 2022.
Cimerli is indicated for patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.
Cimerli launched on Oct. 3, 2022, through U.S. specialty distributors at a list price of $1,360.00 and $816.00 per single-dose vial for the 0.5 mg and 0.3 mg dosages, respectively. This represents a 30% discount from the list price of the reference product, the company noted.
Additionally, through Cimerli Solutions, Coherus offers healthcare professionals comprehensive practice and patient support that includes patient assistance, electronic services and office support to ensure successful access and reimbursement.
“With the upcoming launch of Cimerli, retina specialists, patients and payers can expect the same efficacy and safety as Lucentis delivered with the comprehensive savings and patient support services that Coherus is known to deliver,” said Paul Reider, chief commercial officer of Coherus BioSciences