Biosimilars and Interchangeables: What They Are and Why They Matter

(239 Ratings)

Produced on: October 11, 2018

Course Format On Demand Audio

Taught by


Course Description

Time 60 minutes
Difficulty Beginner

What in the world is a biosimilar? How does one get approval for one? Are interchangeable biosimilars really different? The area of biologics products, until recently thought of as “science fiction,” are now the future of medical innovation. Along with these biologic products come biosimilars and interchangeable biosimilars, essentially alternative biologic product options to the innovator product.

What exactly are these products, how are these products performing in the marketplace, and what hurdles does one have to overcome to obtain licensure from the Food and Drug Administration (FDA)? Some of those answers are much more complex than you think. Seven of the top ten selling pharmaceutical products are now biologic products (with more to come, particularly with the FDA’s newly released Biosimilars Action Plan).  

Get in the know with this program, led by attorneys Ha Kung Wong and John Kirkland, to understand the regulatory and IP impact of these products - and to be ready for the future.

Learning Objectives:

  1. Define “biosimilars” and understand the importance of Interchangeables
  2. Identify potential marketplace impact of biological products
  3. Recognize the current approval pathway for interchangeables
  4. Appreciate the recommendations and goals for FDA Guidances and the new Biosimilars Action Plan


Ha Kung Wong

Venable LLP

Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics and chemistry. Cases Ha Kung has litigated include those related to proton pump inhibitors, anti-epileptic drugs, anti-tussives, psychotropic agents, siRNA and other pharmaceuticals. Mr. Wong also has extensive experience with inter partes review (IPR), post grant review (PGR), intellectual property counseling, pre-suit investigations, licensing and due diligence.

Mr. Wong is the recipient of the 2017 ILO Client Choice Individual Award for Intellectual Property in New York, was named to The National Law Journal’s 2017 inaugural list of Elite Boutique Trailblazers and was recognized as a 2018 LMG Life Sciences Star. He serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a Furthered 40 by Lawline for his contributions. He is also an Advisory Board Member for The Center for Biosimilars.

John W. Kirkland

Alkermes, Inc.

John Kirkland is Director of Intellectual Property at Alkermes, Inc. in Waltham, Massachusetts. At Alkermes, Mr. Kirkland has responsibility for all aspects of U.S. patent disputes, in both judicial and administrative tribunals. Prior to joining Alkermes, Mr. Kirkland was Counsel at Fitzpatrick, Cella, Harper & Scinto, where he advised clients in all aspects of intellectual property matters, including disputes arising under the Hatch Waxman Act. 


Lisa M.

This was probably the most entertaining CLE I have attended to date. While I knew nothing about biosimilars before this course, the examples were fun and relevant and made the topic understandable. Very well done and very engaging!


These guys are the best teachers you have in the whole program

Rebecca S.

Great program, thanks!

Frank C.

fun session.

Shana B.

great dynamic duo, very interesting and informative

Magdaleno G.

These presenters are great! I love how passionate they are about the topic and how they add levity to their presentations. I got a good chuckle out of their commentaries on millennials.

Thomas D.

Great smart presenters, with a sprinkling of humor!

Nancy B.

took s difficult subject and made it fun

Maeve T.


Jonathan S.

Fun course! Good work!

Robert M.

These presenters were very entertaining and understandable

William H.

Good presentation. Faculty met some dense subject matter light and easier to understand.

Alexander M.

Thank you

Elizabeth F.

Thumbs up, Dudes!

Michael M.


Joseph M.

very informative

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