The ‘authorized generic’ version of a drug is an important product consideration for patients, an executive at Sanofi US advised.
“Patients can ask the pharmacist if the medication offered is an authorized generic,” Dr. Cary Yonce, vice president of general therapeutics and life-cycle management at Sanofi, said in an interview with American Pharmacy News. “As a patient, I would ask for that because you know you are going to be getting the same formulation as the original brand.”
That’s incredibly important for those patients who “do have allergies to food coloring or other inactive ingredients” that may be used in a random generic drug, said Yonce, who added that inactive ingredients actually “don't have to be the same as the original brand for oral solids.”
"Authorized generics,” Yonce told American Pharmacy News, “are linked to the original NDA,” or new drug application. In certain states, the U.S. Food and Drug Administration’s NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
In late September, Sanofi launched an authorized generic of Arava Leflunomide tablets through its U.S. generics division, Winthrop.
Leflunomide blocks autoimmune antibodies to reduce inflammation and improve mobility for patients having rheumatoid arthritis, a chronic disease that currently affects more than 1.5 million Americans. Commonly known as RA, the disease causes swelling, pain and deformity in a person’s joints.
Yonce said the company’s new authorized generic for RA is now being sold in a variety of retail outlets.
“It is an identical product that has the same active ingredients and the same inactive ingredients,” Yonce said. “It is important to know that the product that we first got approved for the treatment of RA 17 years ago in 1998 is the same as the authorized generic, so [customers] are getting the same formulation."
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