Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Plenary Session:  Biosimilars, 2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta Hotel, Cambridge, MA

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

covers in REAL TIME

2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta Hotel, Cambridge, MA

 In Attendance, steaming LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

Director & Founder

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

https://www.massbio.org/events/2016-massbio-annual-meeting-1120

2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta, Cambridge MA

http://pharmaceuticalintelligence.com/2016/03/02/2016-massbio-annual-meeting-03312016-800-am-04012016-300-pm-royal-sonesta-cambridge-ma/

Plenary Session:  Biosimilars – Celebrate 10ht birthday next month: Head of Biologic, Tail of Specialty Pharmaceutical

• Sige Gutman, Chair, Life Sciences Patent Practice, Proskauer Rose (Moderator)

1. MOA should be considered different
2. Uptake of one BioSImilar accepted
3. Clinical trials for BioSimilars
4. DPCIA – Congress required exchange of Inforamtion , Upon FDA Approval, no problems of IP Reference Product Sponsor – identify all Patents composition, Methods of Manufacturing, Methods of Composition – WHAT CLAIMS in the applicants in need to wait for expiration. Initial list all paptent, Applicant need to provide information on each applicant as FREEDOM TO OPERATE in the marketplace, if no agreement in 50 days will be litigated, Phase One litigations
5. unenforcability, infingements – ANGEN and SANDOS
6. Is the Patent dance optional? 351K Application – 130 days notive
7. Fedearal Court decided that dance optional is in fact optional – Matter in front of Supreme Court
8. Pharmacovigilenge for BioSimilars – collective initiative on classes of therapies

• Jim Roach, CMO, Momenta

• Alex Waldron, Vice President of Global Commercial Operations, Epirus Biopharmaceuticals

1. 15% discount – will not drive uptake
2. Sandos – in the US using lessons from Europe
3. Sandos – Uptake in Europe was slow
4. poor correlation Price and Market share
5. 2014 – Lauunch in the with SAles Force, Medical Laisons,
6. Fixed Business model help the uptake
7. BioSImilars are expensive and NO pressure to decrease cost
8. no studies done for a=b b=c a=c

• FDA Representative

1. Ex-Vivo will provide bioequivalence