2013 Archived Content
Biosimilars and Biobetters 


Day 1 | Day 2
Download Biotherapeutics Analytical Summit Brochure or Download This Track Brochure 

Monday, March 19

About this conference:

Biosimilars promise to lower costs through increased competition, expand access to medicines, and promote further biomedical innovation. However, biosimilars are subject to an approval process, which requires substantial additional data compiled through clinical, animal and analytical studies. It is thus difficult and costly to recreate biologics. This conference presents strategies for overcoming scientific, regulatory and legal challenges in the development and commercialization of biosimilars, biobetters and biosuperiors. Industry case studies, regulatory advice and interactive breakout discussion groups will be featured.

12:00 pm Registration


2:00 Chairperson’s Opening Remarks

Javier CoindreauJavier Coindreau, M.D., US Head, Clinical Development and Medical Affairs, Sandoz


2:05 Biosimilars: Key Aspects in Technical Development

Carol KirchhoffCarol Kirchhoff, Ph.D., Senior Principal Scientist & Group Leader, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.; Co-developer: Beverly Ingram, Ph.D., Associate Director, CMC Biopharma, Pfizer, Inc.Biography 


Featured Presentation 

2:30 Clinical Development Strategies for Biosimilar Development Programs

Meena SubramanyamMeena Subramanyam, Ph.D., Vice President, Development Translational Medicine, Biogen Idec, Inc. - Biography 

This presentation will focus on clinical development strategies for biosimilar development programs and will elaborate on points to consider in the demonstration of pharmacokinetic and therapeutic equivalence.

2:55 Analysis of the Biosimilar Development Pipeline

Ronald RaderRonald Rader, President, Biotechnology Information Institute - Biography 

The first published study of the biosimilars (and biobetters) pipeline for recombinant proteins and antibodies considered candidates for introduction in the U.S. and European markets reveals many interesting and surprising patterns and trends. The audience will gain a better understanding of how the market will develop and evolve. When will products begin entering the U.S. and European markets? What companies will be active players? Will there be too many biosimilars/biobetters and companies involved? What different development approaches are companies taking? What will be the involvement of companies in the U.S./EU vs. those in developing countries?

3:15 Flexible and Cost-Effective Manufacture of High Quality Biosimilars

Philip BallPhilip Ball, Ph.D., Technical Director, Eden Biodesign (a division of Watson Pharmaceuticals) - Biography 

This presentation will offer an assessment of modern biomanufacturing strategies and describe how they are providing more cost-effective and flexible options for biosimilar development.


3:35 Networking Refreshment Break in the Exhibit Hall with Poster Viewing


3:55 Biosimilars Differentiated Through Novel Drug Delivery Technologies

Robin HwangRobin Hwang, Ph.D., ICP Consulting Corp. - Biography 

Biosimilars have been commercialized in the marketplace with limited success. Product differentiation is essential after the biosimilar is deemed to be comparable to the drug product from the innovator. This talk will address several ways of differentiating biosimilars to gain better market acceptance through novel drug delivery technologies. Both innovative injection devices and sustained release of the biosimilar to reduce the frequency of injections will be discussed. The audience will learn the importance of and options for differentiating their biologics.

4:20 Biomanufacturing Capacity for Biosimilars: Is There Enough?

Patricia SeymourPatricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc. - Biography 

The impending patent cliff for many high-value innovator biopharmaceutical products offers significant opportunities for biosimilar companies, whose market is estimated to grow from $243 million in 2010 to $3.7 billion by 2015 in the United States, Europe, and Japan. One primary success factor for individual companies will be access to biopharmaceutical development and manufacturing capacity, and determining the overall demand and the corresponding capacity requirements for emerging biosimilars can be difficult. In order to decrease cost of goods and maximize returns on investment, biosimilar companies must determine whether to invest in their own manufacturing capacity or outsource the manufacturing to a contract manufacturing organization (CMO). This presentation will explore the effect of biosimilar development on overall manufacturing capacity and will evaluate strategic options for individual biosimilar companies.

4:45 Why BioDifferent Equals BioBetter

Glenn KazoGlenn Kazo, President, Prolong Pharmaceuticals LLC - Biography 

Efforts directed at proving products are BioSimilar may restrict commercial opportunities that are based on product differentiation, however minor or subtle. This talk may redirect thinking to be more in line with the marketing objectives of the organization. Audience will gain a “different” way of viewing what makes a biological product better -- in the market.

5:10 Beyond Biosimilars: Biosuperior Strategies to Extend the Half-life of Therapeutic Antibodies and Fc Fusion Proteins

David SzymkowskiDavid Szymkowski, Ph.D., Senior Director, Biotherapeutics, Xencor, Inc. - Biography 

An understanding of the relative advantages and disadvantages of developing biosuperior vs. biosimilar biologics, and of the technological approaches available to generate improved versions of marketed biologics.


5:35 Breakout Discussions

Table 1: Legal Issues and Implementation of the BPCI Act

Moderator: Kay Holcombe, Senior Health Policy Advisor, Genzyme Corp - Biography 

  • Analysis of the patent environment and freedom to operate
  • Actual implementation steps of the BPCI Act
  • Abbreviated pathway for approval of biosimilars in the US over normal BLA

Table 2: US, EU, Rest of World Regulatory Perspectives and Strategies

Moderator: Umang Shah, Head, Regulatory CMC, Novartis - Biography 

  • How the case-by-case approach works in practice
  • Risk analysis
  • Presenting a comparability package to the regulatory authorities

Table 3: Product Similarity for Biosimilars & Analytical Challenges

Co-Moderators: Patricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc. - Biography 

Danny Chou, Ph.D., Chief Scientific Officer, Protein Characterization, NorthStar Bio - Biography 

  • QbD for biosimilars
  • Biomanufacturing considerations: single use systems
  • Analytical tool kit for demonstrating biosimilarity

Table 4: Biosuperior Development Strategies

Co-Moderators: Maria Barbosa, Ph.D., Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb - Biography 

David Szymkowski, Ph.D., Senior Director, Biotherapeutics, Xencor, Inc. - Biography 

  • Trends, opportunities and development strategies
  • Engineering already clinically validated products
  • What are they – to an innovator co., to a generic co., to a regulator?

6:30 End of Day One of Biosimilars & Biobetters

Day 1 | Day 2
Download Biotherapeutics Analytical Summit Brochure or Download This Track Brochure 


Green arrow2015 Brochure Download


BCC Final Cover