Biotech Values

[genisi]

Complex generics like enoxaparin and glatiramer acetate were submitted and accepted for review under the existing ANDA pathway because there isn't a specific pathway for biosimilars yet. Such legislation is expected in the near future but meanwhile the FDA cannot treat these as standard chemical. Copaxone is more of a biologic drug because its formulation and manufacture are very complexed, its precise MoA has never been fully characterized nor confirmed, after being injected it degrades to small peptides and free amino acids locally, so serum concentrations are too low to be detected (it is not even clear if they need to be in the systemic circulation for their effects), and there isn't any way (test or model) to prove its activity except for clinical trials. I do appreciate Momenta's tech a lot and think it is capable of reverse engineering Copaxone correctly. However, they will have to show safety and efficacy via clinical trials, imo.