Momenta Pharmaceuticals, Inc. (MNTA)

[Goo111]

and...why exactly?

Did you watch the webinar?

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm

Presentation:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM292463.pdf

Was Copaxone not approved under 505?

Is Momenta not seeking approval under 505(j)?

Did the Feb 15 FDA Webinar not announce a NEW definition of the term biologic (that Dr. Sherman specifically said "would interest industry because it's new")?

Did the Feb 15 FDA Webinar not give a TRANSITION PLAN for 505-approved "biologics" (under the new definition) to 351?

Slide 18.

As of March 23, 2020, an application for a biological product approved under section 505 of the FD&C Act will be deemed a biologics license application (“BLA”) licensed under section 351 of the PHS Act.

---- Either way, the FDA appears committed to finding the most efficient pathway, but the February 15 Webinar clearly reveals NEW and relevant information. For efficiency's sake, if Copaxone is deemed a biologic under the new definition (which I don't know at this point), I suspect the approval would happen through 505(j) with a plan to transition it to 351 later on.