Tecfidera Generic Granted Tentative FDA Approval as Patent Assault Continues

US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted tentative approval to Glenmark Pharmaceuticals for dimethyl fumarate delayed-release capsules, a generic version of Biogen’s Tecfidera.¹

The latest generic entry comes on the heels of a new report from The Institute for Clinical and Economic Review (ICER), which published a list of prescription drugs that had substantial price increases in 2017 and 2018 without what they consider to be new supporting evidence.²

Biogen’s blockbuster multiple sclerosis therapy came in at number 7, impacting US spending by $313 million, according to the report. The drug price increases were more than twice the rate of medical inflation, according to ICER. Pfizer’s Lyrica (pregabalin), another drug used to treat neurologic disorders, also made the list at number 3 with a reported $688 million impact on US spending.

Another recent study published in JAMA Neurology highlighted the increasing prices of disease-modifying therapies (DMTs) for MS, noting a persistent rise over a 10-year period.³

The recent used Medicare Part D claims data to conclude that annual costs associated with self-administered DMTs for MS increased dramatically from 2006 to 2016, from a mean of $18,660 to $75,847, representing a mean increase rate of 12.8% yearly, resulting in a roughly 7-fold increase in patient out-of-pocket costs.

Perhaps what is most surprising is that the introduction of new therapies has failed to contain rising drug costs. While the entry of generics typically quell costs, the investigators actually observed an opposite trend.

“Although Teva launched the branded glatiramer 40-mg at a similar price as the branded 20-mg version in 2014, the price of the 20-mg branded formulation increased substantially the following year. This could have represented an attempt to encourage the use of the 40-mg formulation in anticipation of the entry of a generic version for the 20-mg formulation,” they wrote.³

The industry’s reaction to available Tecfidera generics is yet to be seen. Biogen has been facing several patent threats over the last year, with several inquiries on its central 8,399,514, US patent which covers the drug’s twice-daily dosing regimen. Both Mylan and Sawai Pharmaceutical have filed challenges with the US Patent and Trademark Office this year for the ‘514 patent, which expires in 2028.^4,5

In the meantime, other companies have gained tentative approval of generic formulations of the drug, which has other patents that expire this year and in 2020. In December 2018, the FDA granted tentative approval to Lupin for its generic 120-mg and 240-mg formulations. The agency also granted tentative approval in January of this year to Banner Life Sciences’ bafiertam, a novel fumarate bioequivalent to Tecfidera. Final approval for that drug is expected by June 2020.

REFERENCES

1. Glenmark Pharmaceuticals Receives Tentative ANDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg [news release]. Mumbai, India: Glenmark Pharmaceuticals. October 9, 2019. prnewswire.com/in/news-releases/glenmark-pharmaceuticals-receives-tentative-anda-approval-for-dimethyl-fumarate-delayed-release-capsules-120-mg-and-240-mg-880935531.html. Accessed October 9, 2019.

2. ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence [news release]. Boston: ICER. October 8, 2019. icer-review.org/announcements/icer-identifies-costliest-us-drug-price-hikes-that-are-not-supported-by-new-clinical-evidence/. Accessed October 9, 2019.

3. San-Juan-Rodriguez A, Good CB, Heyman RA, Parekh N, Shrank WH, Hernandez I. Trends in prices, market share, and spending on self-administered disease-modifying therapies for multiple sclerosis in Medicare Part D. JAMA Neurol. Published online August 26, 2019. doi:10.1001/jamaneurol.2019.2711.

4. Sagonowsky E. Biogen faces multibillion-dollar Tecfidera loss if Mylan wins latest patent threat. FiercePharma website. February 7, 2019. fiercepharma.com/pharma/biogen-faces-new-patent-threat-from-mylan-blockbuster-tecfidera. Accessed October 9, 2019.

5. House DW. Biogen down 3% on Tecfidera patent review. Seeking Alpha website. September 12, 2019. seekingalpha.com/news/3498955-biogen-3-percent-tecfidera-patent-review. Accessed October 9, 2019.