but to what extent remains to be seen.
26 As a result, biosimilars make biologic
manufacturers nervous about the effect biosimilars may have on their market
27 After Pfizer announced that it would begin to offer a Remicade28
biosimilar “at a 15 percent discount to [Johnson & Johnson’s] current
wholesale prices,” Johnson & Johnson, which manufacturers Remicade, saw
its “shares [fall] more than 2 percent.”
I am also nervous about the effect biosimilars will have, but what I feel is
nervous excitement. I was diagnosed with RA in 1981 at 13 months old.
Although there are more treatments available for RA patients now than there
were in 1981,
30 my disease’s progression has outpaced scientific innovation.
In 2002, I began taking Remicade after less potent RA drugs, including
Celebrex and Methotrexate, failed to control my intense flares. I struggled to
walk and stand, and I was only 22 years old. I took Remicade for about six
26. Lindsay Kelly, Biologics in the Practice of Law, 39 HARV. J.L. & PUB. POL’Y 21, 31
(2016) (explaining that although prices are unlikely to fall “steeply,” a biosimilar launched in
September 2015 was offered at a fifteen percent discount from the biologic price; the RAND
corporation also projects a thirty-five percent price decrease between 2014 and 2024 as
biosimilars are introduced); Guidance for Industry on Biosimilars: Q & As Regarding the
Implementation of the BPCI Act of 2009: Background, U.S. FOOD & DRUG ADMIN.,
806.htm (last updated Feb. 19, 2016) (describing the requirements for a biosimilar application
which needs “information demonstrating that the biological product is biosimilar to a reference
product” through various studies and that biologics have exclusivity over biosimilars for 12
27. See, e.g., Tracy Staton, Aiming to Shield $14B in Sales, AbbVie Smacks Amgen with
a Patent Suit over Humira Biosim, FIERCEPHARMA (Aug. 8, 2016, 9: 58 AM),
patent-suit-over-humira-biosim (describing the patent infringement dispute between AbbVie
and Amgen regarding Amgen’s new Humira biosimilar, and that some companies, like
Amgen, market and profit from both biologics and biosimilars).
28. Christian Nordqvist, Remicade (Infliximab): Uses and Cautions, MED. NEWS TODAY,
http://www.medicalnewstoday.com/articles/248273.php (last updated Mar. 7, 2017)
(explaining that Remicade is a biologic that “reduces inflammation and pain for patients with
autoimmune diseases.” It works by suppressing patients’ immune systems, which can make
patients who take it more susceptible to infection. Also, it must be administered intravenously,
in either a clinic or hospital). Based on my personal experience with Remicade, “infusions,”
the shorthand phrase for each Remicade treatment, take approximately three hours to
complete. Understaffed infusion centers or delays in retrieving the medication from storage
facilities can add up to two hours to the treatment time.
29. Ransdell Pierson, J&J Shares Lose Ground on Fears of Pfizer’s Answer to Remicade,
REUTERS (Oct. 18, 2016, 1: 36 PM), http://www.reuters.com/article/us-johnson-johnson-
results-idUSKCN12I15K; see Zachary Brennan, Genentech Files Complaint over Amgen’s
Development of Avastin Biosimilar, REG. AFF. PROFS. SOC’Y (Feb. 20, 2017),
biosimilar dispute with Avastin).
30. Katherine S. Upchurch & Jonathan Kay, Evolution of Treatment for Rheumatoid
Arthritis, 51 RHEUMATOLOGY vi28, vi28–vi30 (2012) (describing the history of RA treatments,
current treatments of RA, and future therapies for RA).