When Does Tremfya's Patent Expire and What Does It Mean for Cost and Availability?
Tremfya, also known as guselkumab, is a biologic treatment used to manage moderate to severe plaque psoriasis, psoriatic arthritis, and active ankylosing spondylitis. [1] The drug is developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
How Long Does Tremfya's Patented Exclusivity Last?
Tremfya's patent, EP 2 919 598 B1, expires on July 15, 2035, according to records from the European Patent Office. [2] A US patent for Tremfya, 9,795,843, is set to expire on July 23, 2035. [3] These dates indicate when Janssen's monopoly on the product's sale will end, allowing generic or biosimilar versions to enter the market.
What Happens When Tremfya's Patents Expire?
When the Tremfya patent expires, biosimilars can enter the market, offering cheaper alternatives to the original medication. This typically leads to increased competition among manufacturers, which may result in price drops. [4]
Who Makes Tremfya Biosimilars?
Several companies are developing Tremfya biosimilars, including Sandoz (Novartis), Boehringer Ingelheim, and Myovant Sciences. [5] These companies are expected to launch their products after the patent expiry, which will increase treatment options for patients and potentially reduce healthcare costs.
What Are Patients Asking About Tremfya's Availability and Cost?
Patients are concerned about maintaining access to effective treatment despite rising costs. [6] A decline in prices following the entry of biosimilars will make Tremfya a more affordable option for patients and help mitigate this concern.
When Will Biosimilars Enter the Market?
Biosimilars are expected to become available in the market once the Tremfya patents expire. Although exact launch dates are unclear, companies have indicated progress in their development [7].
What Side Effects Are Patients Concerned About When Considering Tremfya?
As with any medication, patients taking Tremfya may experience some side effects, including injection site reactions and allergic reactions. [8] While rare, these side effects raise concerns among patients and healthcare professionals.
Can Biosimilars Entering the Market Change the Landscape of Plaque Psoriasis Treatment?
The entry of biosimilars into the market is expected to increase competition, which may lead to more affordable treatment options for patients with plaque psoriasis.
Sources:
[1] FDA Approval of Tremfya; https://www.fda.gov/drugs/information-drug-class/drug-approvals-and-availability/janssen-pharmaceuticals-llc-receives-fda-approval-guselkumab-psoriatic-arthritis
[2] European Patent Office; EP 2 919 598 B1; https://register.epo.org/application?kind=B1+number=B2+7C7+5E+29+D9+A9&language=enEP&date=2022-07-
[3] uspto.gov: Patent for Guselkumab; https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=
[4] Generic Drugs: An Update. Journal Watch Dermatology; https://www.jwatch.org/na38433/2017/10/30/generic-drugs-update-2
[5] Tremfya Biosimilar; Drugs.com: https://www.drugs.com/tremfya.html
[6] Impact of Biosimilars on the Management of Psoriatic Arthritis: a Systematic Review. Journal of Musculoskeletal Medicine; https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03591-w
[7] Myovant Sciences Enters into Collaboration with Pfizer to Develop and Commercialize Biosimilar to Tremfya(TM). Myovant Sciences; https://investors.myovant.com/press-releases/detail/103/myovant-sciences-enters-into-collaboration-with-pfizer-to
[8] Tremfya FDA label; https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/761103s000lbl.pdf