June Event: Using Legos and Pyramids to Explain Biosimilars: Updates, Challenges and Opportunities


Using Legos and Pyramids to Explain Biosimilars:Updates, Challenges and Opportunities

Wednesday, June 19, 2019


Event Agenda:

Date: Wednesday, 19 June 2019


5:15 – 6:00 PM Registration, Snacks, & Networking

5:30 – 5:55 PM Speed Networking

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A *Times are approximate.


Hubert C. Chen, MD

Chief Medical Officer, Metacrine

Medical & Scientific Advisor, Pfenex

Program Topic:

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments– biosimilars – to markets around the world. Biosimilars, also known as biological products that are demonstrated to be “biologically similar” to or interchangeable with an FDA-approved biological product, offer cost savings for some of the most expensive medicines. However, even today after decades of companies starting their quests to develop biosimilars, they are only just beginning to see widespread adoption.

Currently, there are more than 150 reference products for biosimilars which offer promise of new, cost-saving competition despite the many manufacturing and approval challenges. From the regulatory perspective, a number of agencies have adopted principles from the US and/or the EU biosimilar guidances. However,specific guidelines are yet to be established for some major markets. A global development strategy is still evolving and, in time, it will determine how biosimilars will be regulated and marketed globally.

Key topics covered will include:

  • Introduction to biosimilars

  • Review of regulatory and commercial experience: Comparing/contrasting US vs EU

  • Case study: a biosimilar/therapeutic equivalent candidate referencing Forteo for the treatment of osteoporosis

  • Challenges & opportunities with developing biosimilar products

Speaker Biography:

Hubert C. Chen, MD, is the Chief Medical Officer of Metacrine and Medical & Scientific Advisor at Pfenex. He previously served as Chief Scientific and Medical Officer of Pfenex, where he oversaw the research and development of biosimilar programs and led multiple interactions with the US FDA, EMA, Health Canada and Japan's PMDA.


Pfizer Inc.

10770 Science Center Drive (visitors center)

Conference Room #1110

San Diego, CA 92121

** Please make your reservation early. The pre-registration due date is Monday, 17 June 2019. Advanced registration is appreciated to assist in event planning.

** Space is limited for our monthly programs. Registration is capped at 85 participants. Register today to ensure your seat. Once our limit is reached, registration will close. Events with closed registration will not allow walk-ins.

Online registration (through Monday 17 June 2019 ): $15 SDRAN Member

$25 Non-Member

Onsite Registration: $25 SDRAN Member

$35 Non-Member

For Questions Email: programs@sdran.org


From the North:

I-5 South toward San Diego

Take Exit 29, turn left into Genesee Ave

Turn right onto Science Center Dr

CB2 Visitors Center is located at the end of the cul-de-sac

From the South:

I-5 North toward Downtown

Take Exit 29, turn right into Genesee Ave

Turn right onto Science Center Dr

CB2 Visitors Center is located at the end of the cul-de-sac