Pills, Biologics, Generics, Biosimilars

There are two distinct kinds of treatment medications: pills and biologics. 

Pills are pure chemical substances with relatively small, simple and repeatable structures or formulas.  They are easy to replicate due to their size, structure and controlled manufacturing processes.  Many of doctor-prescribed or over-the-counter brand name pills can be produced and dispensed as "generics" after the patented period attributed to the manufacturer of the drugs expires. The generics work exactly like their brand name counterparts.  The time it takes a generic drug to appear on the market varies. 

Biologics, on the other hand, are treatments created from a variety of living cells and they are all but impossible to replicate. They are largely designed by genetically re-engineering DNA cells and are almost always injected into patients.  Many biologic medicines work by providing proteins that healthy individuals possess, but patients lack; others target specific diseases.  Because of the nature of biologics, there cannot be "exact copies" of them, only "similar copies."  Hence, there are no "generic biologics," only "biosimilars."

Biologics represent the cutting edge of medical science in the U.S. and the world, and are being used to successfully treat some of the most severe diseases like cancer, heart disease, arthritis, AIDS and more. Benlysta, the lupus treatment approved earlier this year by the FDA, is a biologic.

In the U.S. patents for pills give 20 years of protection, but they are applied for before clinical trials begin, so the effective life of a pill patent hovers around 7 and 12 years.  On the other hand, biosimilar products can be marketed after an innovative biologic has been available for 12 years, or after the patents expire.

First generation biologics will soon contend with an open market for similar versions of themselves. The U.S. currently has a legal pathway under the Public Health Service Act (PHSA) for approving biosimilars, although a formal regulatory process is still being established by the FDA.

Read more about biosimilars. 

2011 Fall Mini-Conference:

"Meds, Diet and Movement" 

Saturday, November 5, 2011 | 11am to 4pm

Kaiser Santa Clara | Room HOS B-6

710 Lawrence Expressway | Santa Clara, CA 95051

Mizuno

Shibuya

Stellmon

Speakers: Barry Shibuya, MD, rheumatologist and president of the Northern California Rheumatology Society | Kandice Stellmon, certified nutrition consultant | Regan Mizuno, certified fitness instructor.  Featuring a panel of young adult lupus patients. 

REGISTRATION REQUIRED.  Click HERE  for details.

In partnership with

Patient Education Classes (English & Spanish), Santa  Clara | October 22, 2011 

LFNC is offering a basic class for newly or recently-diagnosed lupus patients and their families and an intermediate class for long-time patients wanting to learn more about disease management. Click HERE  for details.  REGISTRATION REQUIRED.

LRI National Coalition Urges Congress To Protect Medicare Part D

As the Joint Select Committee on Deficit Reduction examines ways to reduce federal spoending, the LRI National Coalition formally requests the committee to carefully consider the impact of any Medicare Part D changes on lupus patients. Read letter.