The Food and Drug Administration (FDA) approved or tentatively approved nearly 470 generics and biosimilars by July 2021, according to Drug Topics.
Last year, the FDA approved a generic form of varenicline during which the United States and the world continued to fight the COVID pandemic. However, in July 2021, Pfizer, which develops Chantix (varenicline), recalled certain lots of the drug due to the presence of a carcinogen called nitrosamine.
Varenicline is a nicotine-free prescription pill that is used as a smoking cessation aid.
In August 2020, the FDA approved generic varenicline of US-based drug company Par Pharmaceutical. It is currently not available in the United States, but a generic version of varenicline (Apo-Varenicline) is, which is developed by Apotex.
In August 2020, the FDA also approved Comirnaty (mRNA-based COVID vaccine) developed by Pfizer-BioNTech. In December 2020, the agency announced emergency approval of the Moderna COVID vaccine, and in January 2021, the FDA approved Johnson & Johnson vaccine.
In 2020 alone, the U.S. drug regulatory body approved or tentatively approved 948 Abbreviated New Drug Applications (ANDA). In 2019, it approved or tentatively approved more than 1000 generic drug applications. And through July 2021, the FDA approved or tentatively approved 470 generics and biosimilars.
Dr. Francis Palumbo of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy in Baltimore described the FDA’s approval rate of generic drugs as “impressive.”
Among the approved generic drugs, Dr. Palumbo highlighted three generic drugs for pain relief, HIV, and multiple sclerosis (MS).
In June 2021, Indian pharma company Lupin announced that the FDA had approved generic Truvada (Emtricitabine/tenofovir disoproxil fumarate) for the treatment of HIV. It is the generic version of the brand Truvada, developed by Gilead Sciences.
Dr. Palumbo said the approval of generic Truvada will “introduce competition in the marketplace. That’s going to reduce barriers to access [for this treatment,] which will ultimately improve [clinical] outcomes.”
In August 2020, the FDA approved generic Tecfidera (dimethyl fumarate) for the treatment of relapsing forms of MS, which is manufactured by Mylan.
Kathy Costello, Vice President of Healthcare Access for the National Multiple Sclerosis Society, said, “Generic options will increase the affordability of and access to MS disease-modifying therapies, which are the cornerstone of MS management.”
In December 2020, the agency approved generic Ofirmey (acetaminophen) for pain relief, developed by Leucadia Pharmaceuticals. Dr. Palumbo said, “It’s important to have access to [acetaminophen injection] because it’s not an opioid.”
Leucadia CEO William Larkins said, “The release of this latest generic injectable once again demonstrates Leucadia’s strategic focus on expanding access to safe, effective pharmaceuticals at substantially lower costs.”
In July 2021, the FDA approved the first interchangeable biosimilar insulin. It approved Semglee (insulin glargine), a biosimilar to and interchangeable with insulin glargine (Lantus), a long-acting insulin analog.
Neil Gilchrist, Chief Pharmacy Officer at UMass Memorial Health in Worcester, Massachusetts, said the approval of Semglee is a “most notable” approval over the past year.
He said the generic approval of this product will help innumerable patients with type 1 and type 2 diabetes who often rely on insulin to stay alive. More importantly, the approval of Semglee will help a pharmacist to switch a patient’s prescription from brand to generic, saving money.
