and other symptoms.”
Biologics have molecular structures “usually 100 to 1,000 times” larger
than drugs like aspirin, known as “small molecule drugs.”
11 Small molecule
drugs are made up of “relatively simple chemical compounds” that can be
12 Because biologics are structurally complex, “it is more
difficult to determine whether one biological drug is actually identical to
13 Thus, there is no such thing as a “generic” biologic.
biologic copies are known as biosimilars15 and replicate biologics with
“highly similar, but slightly variant, living organisms or processes . . . .”
Biologics are not only the most effective kind of medication for certain
autoimmune diseases, but also the most expensive17 and financially
burdensome, even for the privately insured.
18 A small molecule drug costs
approximately $2 a day, whereas “[i]n 2013, the average daily cost in the
United States of a biologic drug was $45 . . . .”
19 If the Affordable Care Act’s
pre-existing condition protection is eventually repealed, many patients
treated with biologics may lose their health insurance and be forced to
purchase biologics out-of-pocket (or not at all).
10. Peter C. Taylor, Biologic Therapies for RA, in BIOLOGICS . . . THE STORY SO FAR:
PATIENT GUIDE TO BIOLOGIC THERAPIES IN THE TREATMENT OF RHEUMATOID ARTHRITIS
11. Stacey L. Worthy & John F. Kozak, Follow-On Biologics: Protecting Consumers
Through State Pharmacy Law in Light of FDA Actions, 17 QUINNIPIAC HEALTH L.J. 207, 220
12. Id. at 217.
13. Jason Kanter & Robin Feldman, Understanding and Incentivizing Biosimilars, 64
Hastings L.J. 57, 59 (2012) (explaining that biologics’ complexity increases their cost); What
Are “Biologics” Questions and Answers, U.S. Food & Drug Admin.,
R/ ucm133077.htm (last updated Aug. 5, 2015) (stating that “most biologics are complex
mixtures that are not easily identified or characterized”).
14. Kanter & Feldman, supra note 13, at 59.
16. Joanna M. Shepherd, Biologic Drugs, Biosimilars, and Barriers to Entry, 25 HEALTH
MATRIX 139, 143 (2015).
17. Rheumatoid Arthritis Treatment Costs, Rheumatoid Arthritis,
https://www.rheumatoidarthritis.org/treatment/costs/ (last updated Aug. 3, 2016) (describing
biologics as “the most expensive forms of medications available to patients” being treated for
RA and “[a]dding to the expense is the fact that biologics are usually administered by a
healthcare professional through an IV or by injection” which “alone creates additional health
care costs.”); see also Curtis & Singh, supra note 4, at 697 (“The treatment of RA places a
substantial financial burden on healthcare systems and individual patients. Indeed, a major
problem associated with the use of biologics is cost . . . . Estimates show that the introduction
of biologics has increased, 3-fold, the total annual direct cost of treating RA patients.”).
18. Curtis & Singh, supra note 4, at 697.
19. Jon Tanaka, “Shall” We Dance? Interpreting the BPCIA’s Patent Provisions, 31
BERKELEY TECH. L.J. 659, 661 (2016).