Biosimilar Players Will Be Manufacturers Large And Small, Analyst Predicts
The biosimilar manufacturing and development process has been optimized to ensure multiple companies can enter the market, Sanford C. Bernstein & Co. Senior Health Care Analyst Ronny Gal argues, but uncertainty will remain until FDA designs its approval system.
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The generic market is moving toward more complex products and formulations, which will separate companies based on capabilities, CEOs said at the Generic Pharmaceutical Association annual meeting.
The deputy director of FDA's Europe Office discusses the collaboration between FDA and the European Medicines Agency; the agencies are looking for ways to develop a common biosimilar development program.
Agency says pre-marketing application meetings will not be mandatory; program independence issue also appears resolved.