February 7, 2017 Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product. This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars. Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward

1. Petrie Flom: Looking Forward
February 7, 2017
Panelist: Bob Langer

2. Biologics present unique delivery challenges
• Small molecules vs biologics
• Unique challenges for biologics
• Thick solution requires large volume doses
• Inherently less stable than small molecules
• Approaches to improve dosing
• Drug-based
• Change the drug itself, making a new drug
• Delivery-based
• Oral with additives to increase absorption
• Oral - to be more constant
• Topical with additives to increase skin permeability
• Injectable – to last for a long time
• Local – to reduce toxicity
• Not all work for biologics
• Need unique solutions designed for biologics
• New “biobetter” technology
• Additives thin drug solution
• Enable reduced dose volume
• Facilitate rapid home delivery
• Use with biosimilars and other biologics
http://drexelmedicine.org/patient-services/rheumatology/services/
http://www.huffingtonpost.com/2013/11/22/h5n1-bird-
flu-vaccine-fda_n_4326148.html
Small molecule Biologic
Hospital infusion Injection

3. Delivery-based solutions are broadly beneficial
Patients Providers Industry
Reduced administration costs
Improved access and convenience
Increased compliance
Improved efficacy
No risks from drug
development
Faster to market than developing a new drug
Platform technology
Need policy in place to support all players before products reach market
Improved safety