Despite an absence of specific guidelines from the FDA, companies including Pfizer and Hospira are wasting no time developing biogenerics to ensure they are in the forefront of the market. Hospira Chief Scientific Officer Sumant Ramachandra predicted that the guidance will not be finalized until next year, but an FDA spokeswoman said the agency has formed a task force to create detailed policy and procedures for approving generic versions of biotech drugs.

Related Summaries