Bryan J. Vogel
The role of scientific justification in the nascent US biosimilars approval pathway
Ben Kaspar
The role of patents in biosimilars and biobetters
Brian R. Dorn
Free to sell your biosimilar? The effect of the new FDA rules
D?vorah Graeser
Understanding exclusivity periods in the Biologics Competition and Innovation Act of 2009 (BPCI Act)
Susan K. Finston
What you can?t see just might hurt (or maybe help) you and maybe someone else
C. Patrick McAtee
Regulatory consideration of the assessment of biosimilar products
Jun Wang
Some statistical issues on the evaluation of the similarity and interchangeability of biologics
Laszlo Endrenyi
Joachim Stellmach
Economic and regulatory scenario for biosimilars in Latin America
Valderilio Feij? Azevedo
Biosimilars in emerging countries: Argentina
Gustavo Helguera
Developing biosimilars: Considerations, opportunities and challenges
Ming Wang
William Velander
Kelly S. Colletti
Inge Thomsen Bernstein
Melody Sauerborn
Applications of nanotechnology in drug delivery
R.M. Khalil
Biosimilars: Lessons learned from development to commercial launch
Niranjan M. Kumar
PEG-Modified biosimilars: Potential role in the emerging global biosimilar market
Pascal Bailon
Hong Zhao
High-Quality combinatorial approaches for protein discovery and development
Luke H. Bradley
Biosimilar market overview, present and future
Leandro Mieravilla
Marlene Shehata, Fady Youssef
Biosimilars ? From conformation, ligand binding and stability
Rohanah Hussain
Fuad Fares
Glucagon biosimilar: New perspective for low-price biopharmaceutical products for SUS
Patricia Barbosa Pelegrini
Veysel Kayser and Bernhardt L. Trout
Plant expression platforms for human therapeutic proteins: A new era for biopharmaceuticals
Kathleen L. Hefferon
Plant-based production and preclinical analysis of biosimilar Trastuzumab
Michael D. McLean, Frey Garabagi, Gabrielle Richard, John Teat, Erin Gilbert, Jessica Rouleau, Wing-Fai Cheung, Don Stewart, Roger MacKenzie, Herta Steinkellner, J. Christopher Hal
Immunological aspects of formation of anti-drug antibodies against aggregated protein drugs
Melody Sauerborn
Approach for development of ?-3 phospholipid dietary supplement to potential lipid drug
Su Chen
Bioanalytical challenges in development of biosimilars
Carmine Lanni
Role of process controls in mitigating the risk associated with manufacturing of biosimilars
Indu Javeri
Current analytical techniques for analysis of carbohydrate containing biosimilars
Parastoo Azadi
A case study: Scientific challenges for the bioanalytical method development of biosimilars
Rafiq Islam
Rapid characterization of formulations: Protein size, aggregate levels and viscosity
David M Goodall
Effects of drying technology and polymers on integrity and biological activity of proteins
Amal Ali Elkordy
Paul R?sch