3 These wonder drugs, known as biologics, gave patients who
failed conventional RA treatments4 the ability to function in ways never
5 For RA patients, “the availability of new biologic
treatments . . . transformed management of [their] disease . . . .”
the most effective RA medication for purposes of reducing joint damage,
even help patients increase their workforce presence by reducing the number
of days they must miss from work due to their disease.
Biologics are made “by extracting cellular proteins from animals.”
are “complex, protein-based drugs,” that include medications such as insulin,
Enbrel, and other “monoclonal antibodies,” which treat RA and similar
autoimmune diseases, as well as drugs that treat cancer and multiple
9 The biologics used to treat RA “work by blocking the activity of a
key chemical or cell involved in inflammation that gives rise to joint swelling
3. Carol M. Ostrom, What’s Behind the Whopping Price Tags on the Newest Generation
of Drugs, SEATTLE TIMES (Aug. 17, 2008, 11: 36 PM), http://www.seattletimes.com/seattle-news/health/whats-behind-the-whopping-price-tags-on-the-newest-generation-of-drugs/
(“Rheumatoid arthritis is a nasty disease. Unchecked, the inflammation, destructive changes l
to joints and dissolution of bone it causes — along with the pain — can lead to disability, lost
work time and the need for orthopedic interventions.”).
4. Jeffrey R. Curtis & Jasvinder A. Singh, The Use of Biologics in Rheumatoid Arthritis:
Current and Emerging Paradigms of Care,
33 CLINICAL THERAPEUTICS 679, 680– 81 (2011)
(explaining that before the advent of biologics, conventional RA treatments included
combinations of non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen), analgesics,
glucocorticoids (e.g., prednisone, methylprednisolone), and disease-modifying anti-rheumatic
drugs.); Using Biologic Drugs to Treat Rheumatoid Arthritis, CONSUMER REP. (Mar. 2013),
arthritis/ index.htm# [hereinafter CONSUMER REPORTS] (“Between 30 to 70 percent of people
who have not benefitted from other rheumatoid arthritis medications experience some measure
of relief from biologics.”).
5. Curtis & Singh, supra note 4, at 679, 682, 684 (explaining that in contrast to prior
methods of treatment, “biologics are highly effective in reducing RA symptoms, slowing
disease progression, and improving indices of physical function and quality of life. Clinical
responses are often rapid [as] most patients experience improvements within a few weeks of
starting treatment” or even “a few days after the first dose.”); Lene Andersen,
Guide to RA: Biologics, HEALTHCENTRAL (Dec. 3, 2014),
(“Biologics were a revolution in RA treatment . . . [causing] a seachange, not only in the rates
of control of RA, but also in how it is treated. Biologic medications are very effective in
treating RA, leading to a significant amount of people with RA achieving remission or low
6. Curtis & Singh, supra note 4, at 679–80.
7. Paresh Chaudhari, The Impact of Rheumatoid Arthritis and Biologics on Employers
and Payers, 5 BIOTECHNOLOGY HEALTHCARE 37, 40 (2008).
8. Brian R. Bouggy, Follow-On Biologics Legislation: Striking a Balance Between
Innovation and Affordability, 7 IND. HEALTH L. REV. 367, 368 (2010).
9. ANDREW W. MULCAHY ET AL., THE COST SAVINGS POTENTIAL OF BIOSIMILAR DRUGS
IN THE UNITED STATES
1 (2014), https://www.rand.org/content/dam/rand/pubs/