Armitage’s Leadership in the Pathway to Biosimilars Act

Bob Armitage, Lilly's Sr. Vice President and General Counsel, was named one of The 25 Most Influential People in Intellectual Property by American Lawyer. Armitage was recognized for his leadership role in negotiations on the Pathway to Biosimilars Act, legislation that creates a pathway for approval of generic biologics, commonly called biosimilars or follow-on biologics.

Because I cannot resist the temptation for a brainteaser, here is a quick quiz on the difference between a biologic and chemical entity.  Pick the numbers that correspond to a biologic entity:

  1. Large molecule derived from a living cell
  2. Small molecule chemically synthesized
  3. Often injected
  4. Often taken orally
  5. Challenging to make, transport, and store
  6. Possible to reverse engineer
  7. Complicated manufacturing process that can be effected by elevation, temperature, humidity, etc.
  8. Replicable manufacturing process.

If you picked all of the odds for the characteristics of a biologic, then you are correct.  Developing and manufacturing a biologic compound is significantly more complicated than a chemical entity and therefore requires different governing laws.

A generic pathway for chemical molecules has been available since the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly referred to as Hatch-Waxman) which provided a pathway for generic pharmaceutical medications to come to market. Hatch-Waxman provided financial incentives for research and development while allowing generic competition to enter the market.  The Pathway to Bioismilars Act will allow a similar pathway for generic biologics.

The Pathway to Biosimilars Act provides innovative companies with 12 years of data exclusivity for new biologics, encouraging biopharmaceutical companies to  invest in new molecules. This process provides assurances that would not exist with patent protection alone and ensures that patients have access to safe and effective medicines.