Biotech Values

[DewDiligence]

(MNTA)—FDA FoB guidelines to be published in 2014:

http://t.co/x0zgEJV1SR

• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

• Considerations in Demonstrating Interchangeability to a Reference Product

• Labeling for Biosimilar Biological Products

• Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

The bold-faced item is probably the most consequential one for MNTA (h/t @biosimilarz).

See #msg-65845219, #msg-49883723, and #msg-26837144 for related information.