Notable FDA Generic and Biologics Approvals During the Past Year

Cigarette smoking stubbornly remains the leading cause of preventable disease, disability, and death in the United States.1 Each year, approximately 1 in 5 deaths—or more than 480,000 people—are attributed to cigarette smoking.²

The good news is fewer people are smoking. Nearly 21% of US adults were smokers in 2005, and in 2019, approximately 14% of adults smoked cigarettes.¹

The bad news is that in July, Pfizer, Inc announced that it would recall certain lots of Chantix (varenicline), a nicotine-free prescription pill that can support smoking cessation, due to the presence of a nitrosamine that can cause cancer in patients who ingest it over a long period of time.3,4 On September 17, the FDA issued an update for patients and health care professionals that Pfizer is expanding its voluntary recall to include all lots of Chantix 0.5 mg and 1 mg tablets.⁵ 

Erin Fox, PharmD, BCPS, FASHP, senior director, drug information and support services at University of Utah Health in Salt Lake City, said drug information services at University of Utah started tracking the shortage of Chantix in June.6 Within a span of 3 months, the FDA started to provide alternatives for smokers who wanted to quit. In July, the agency allowed for the import into the United States of Apo-Varenicline (varenicline tartrate), a non-FDA approved generic drug from Apotex Inc, a Canadian company.6 In August, the FDA approved a generic form of varenicline from US-based Par Pharmaceutical.⁷

Although the generic product from Par Pharmaceutical isn’t currently available, the generic from Apotex is, said Fox.

An Impressive Generics Approval Rate 

The approval of a generic form of varenicline is just one of the generics approved by the FDA in the last year, during which the United States and world continued to struggle with the COVID-19 pandemic. In August, the FDA issued full approval of Comirnaty (COVID-19 Vaccine, mRNA), Pfizer’s 2-dose vaccine for people 16 years and older.8 The federal agency provided emergency use authorization for COVID-19 vaccines from Moderna, Inc. in December 20209 and Janssen in January 2021.10

Given the agency’s focus on authorizing the use of COVID-19 vaccines, Francis Palumbo, PhD, JD, professor and executive director of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy in Baltimore, described the rate at which the FDA approved generics during the last year as “impressive.” 

In 2020, the FDA approved or tentatively approved 948 abbreviated new drug applications.11 These applications contain data that are submitted to the FDA for the review and potential approval of a generic drug product. In 2019, the agency approved or tentatively approved 1014 generic drug applications.¹²

Through July of this year, the FDA approved or tentatively approved 470 generics.¹³

Generics for HIV, MS, and Pain Relief

Palumbo highlighted 3 generics approved by the FDA over the last year for HIV, multiple sclerosis (MS), and mild to severe pain.

In June, Lupin Limited announced that the FDA had approved emtricitabine and tenofovir disoproxil fumarate tablets 200 mg/300 mg as a generic equivalent of Gilead Sciences’ Truvada.¹⁴

According to Lupin Limited, this treatment is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections, in addition to being used for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection.

Approximately 1.2 million people in the United States have HIV, a condition that has a more significant impact on certain populations, including racial ethnic minorities and gay, bisexual, and other men who have sex with men.¹⁵

Palumbo said the approval of a generic form of Truvada will “introduce competition in the marketplace. That’s going to reduce barriers to access [for this treatment,] which will ultimately improve [clinical] outcomes.” He added that another benefit of having a generic equivalent to Truvada for the treatment of HIV is the lower incidence of shortages because more than one company now manufactures the product.

Palumbo also pointed to the FDA’s approval in August 2020 of a generic equivalent of Biogen Inc’s Tecfidera (dimethyl fumarate) for the treatment of relapsing forms of MS as a defining generics approval.16 The generic will be manufactured by Mylan.

“Generic options will increase affordability of and access to MS disease-modifying therapies, which are the cornerstone of MS management,” said Kathy Costello, MS, ANP-BC, MSCN, associate vice president of clinical care at the National MS Society.¹⁷ 

MS is potentially disabling disease of the brain and spinal cord; nearly 1 million people in the United States are living with MS.¹⁸ 

The FDA’s December 2020 approval of Leucadia Pharmaceuticals’ generic form of Ofirmev (acetaminophen), an injectable form of pain relief used during surgical recovery,19 was a pivotal decision, said Palumbo. “It’s important to have access to [acetaminophen injection] because it’s not an opioid,” he noted.

In a Leucadia Pharmaceuticals’ news release about the approval, William Larkins, PhD, chief executive officer, 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.”

First FDA-Approved Interchangeable Biosimilar Insulin

Neil Gilchrist, PharmD, MBA, chief pharmacy officer at UMass Memorial Health in Worcester, Massachusetts, said the FDA’s July approval of insulin glargine-yfgn (Semglee)—which is biosimilar to and interchangeable with insulin glargine (Lantus), a long-acting insulin analog—is a “most notable” approval over the past year. What gives it that distinction, said Gilchrist, is the sheer number of patients with type 1 and type 2 diabetes who rely on the medication. 

Approximately 34 million Americans—slightly more than 1 in 10—have diabetes.20 There’s a higher incidence of new diabetes cases among non-Hispanic Blacks and people of Hispanic origin than other ethnic groups, according to the CDC’s 2020 National Diabetes Statistics Report.

The list prices of many common types of insulin have tripled during the past 10 years. According to a spokesperson for Novo Nordisk, however, approximately 80% of people in non–high-deductible plans pay $50 or less each month for one of the company’s insulin analogs.²¹

Novo Nordisk’s NovoLog rapid-acting insulin product that lowers blood sugar spikes in adults and children with diabetes has 41% of the global market share by revenue.²² 

The approval of an interchangeable biosimilar for insulin is important for patients because it means that, for the first time, a pharmacist can switch a patient’s prescription. The potential impact on patients: a lower copay at the pharmacy counter, said Gilchrist, who encouraged pharmacists to explain to patients that the interchangeable biosimilar insulin is an equally effective and safe drug that delivers the same clinical outcome. Equally important, he added, is educating prescribing clinicians to ensure effective care coordination.

References

1. Current cigarette smoking among adults in the United States. CDC. Updated December 20, 2020. Accessed August 27, 2021. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm
2. The health consequences of smoking—50 years of progress. US Department of Health & Human Services. 2014. Accessed August 27, 2021. https://www.ncbi.nlm.nih.gov/books/NBK179276/pdf/Bookshelf_NBK179276.pdf
3. Pfizer issues a voluntary nationwide recall for twelve lots of Chantix (varenicline) tablets due to n-nitroso varenicline content. News release. Pfizer Inc. July 16, 2021. Accessed August 27, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso
4. Varenicline tablets (Chantix). American Society of Health-System Pharmacists. Updated July 21, 2021. Accessed August 27, 2021. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=739&loginreturnUrl=SSOCheckOnly
5. FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix). News Release. FDA; September 17, 2021. Accessed October 8, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix.
6. Importation of Apotex Inc.’s Canadian approved Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg (based on free base equivalents) tablets to address drug shortage. FDA. July 6, 2021. Accessed August 27, 2021. https://www.fda.gov/media/150799/download
7. Varenicline. FDA. Accessed August 27, 2021. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201785
8. FDA Approves first COVID-19 vaccine. News release. FDA. August 23, 2021. Accessed August 27, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
9. Moderna COVID-19 vaccine. FDA. Updated August 18, 2021. Accessed August 27, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine
10. Janssen COVID-19 vaccine. FDA. Updated August 2, 2021. Accessed August 27, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine
11. FDA. Office of Generic Drugs 2020 Annual Report. Accessed August 27, 2021. https://www.fda.gov/media/145793/download#page=8
12. 2019 Office of Generic Drugs Annual Report. FDA. Updated August 26, 2021. Accessed August 27, 2021. https://www.fda.gov/drugs/generic-drugs/2019-office-generic-drugs-annual-report
13. Generic drugs program activities report - monthly performance. FDA. Updated August 11, 2021. Accessed August 27, 2021. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drugs-program-activities-report-monthly-performance
14. Lupin launches emtricitabine and tenofovir disoproxil fumarate tablets in the United States. News release. Lupin Limited. June 25, 2021. Accessed August 27, 2021. https://www.lupin.com/lupin-launches-emtricitabine-and-tenofovir-disoproxil-fumarate-tablets-in-the-united-states/
15. Fast facts. FDA. Updated June 2, 2021. Accessed August 27, 2021. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
16. Dimethyl fumarate. FDA. Updated June 2, 2021. Accessed August 27, 2021. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210531
17. FDA approves generic form of Tecfidera for relapsing MS. News release. National Multiple Sclerosis Society. September 2, 2020. Accessed August 27, 2021. https://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Generic-Form-of-Tecfidera-for-Relapsi
18. How many people live with MS? National Multiple Sclerosis Society. Accessed August 27, 2021. https://www.nationalmssociety.org/What-is-MS/How-Many-People
19. Leucadia Pharmaceuticals Launches Acetaminophen Injection. News release. Accessed August 27, 2021. https://leucadiapharma.com/wp-content/uploads/2020/12/Leucadia-Pharma_Acetaminophen-Injection-Release.pdf
20. CDC. National Diabetes Statistics Report, 2020. Updated February 11, 2021. Accessed August 27, 2021. https://www.cdc.gov/diabetes/library/features/diabetes-stat-report.html
21. One chart reveals how the cost of insulin has skyrocketed in the US, even though nothing about it has changed. Insider. September 18, 2021. Accessed August 27, 2021. https://www.businessinsider.com/insulin-price-increased-last-decade-chart-2019-9
22. Knox R. Insulin insulated: barriers to competition and affordability in the United States insulin market. Journal of Law and the Biosciences. October 9, 2020. Doi: https://doi.org/10.1093/jlb/lsaa061