Replies to post #120024 on Biotech Values

[ghmm]

Nice article so the FDA is basically saying partner with Momenta or do more trials :-). It seems substitutability is unlikely in near term horizon.

I know it may be a bit simplistic but I know Replagal and Fabrazyme have had switches and I suspect with Genzyme's manufacturing problems a fair number of Gaucher patients switched too. So it doesn't seem unprecedented to me for the big concern mentioned in the article about being able to go back and forth from the innovator to a generic.

[DewDiligence]

The BioCentury FoB article gets to the crux of the issue: Should a company develop an FoB, where the clinical program can be somewhat abbreviated and FDA approval in one indication may extend to related indications (#msg-58469454)… or should a company develop a regular biologic (via the BLA pathway), and thereby avoid disclosing IP to competitors?

If an applicant expects to achieve interchangeability, the FoB pathway is clearly preferable; however, if interchangeability is out of the question, the answer to the above question is not easily determined.

[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.