I don't mean to spam, having just posted this on the MNTA site, but it has application for all biosimilars, I will post here too.
For those of you who haven't seen this week's New England Journal of Medicine, there is a critical editorial by Janet Woodcock, et al in the FDA's Center for Drug Evaluation and Research, titled, "Developing the Nation's Biosimilars Program." These are the people who will approve generic Copaxone.
The article isn't available online yet, but key points are below.
1) It appears to be laying out for the public the argument that a "totality of evidence" approach to approval of biosimilars will be the method they endorse. Since this has been MNTA's approach, overall it is a very encouraging piece for MNTA holders.
2) They go out of their way to establish that ". . . the abbreviated pathway will eliminate unnecessary (and therefore unethical) testing of biosimilars in animals and humans." The addition of 'unethical' strikes me as a powerful philosophical statement that given sufficient other evidence, the requirement of human trials for approval is not only wasteful, it is ethically wrong. Advantage, MNTA.
3) They describe this "totality of evidence" approach writing that "since it seems possible to exceed a current state-of-the-art analytic characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary strategies. There may be strategies that allow a 'fingerprint'-like identification of very similar patterns in two different products." This is exactly what MNTA's unique strength is -- as made clear by,
4) The fact that they then go on to specifically mention the method of (what we know is MNTA's) successful approach: "Such strategies were used in support the approval of a generic low-molecular weight heparin product, enoxaparin -- which athought it differs from proteins in important ways, is structurally complex."
5) They mention how the EMA's guidelines are increasingly agreeing with this approach, endorsing "a U.S. biosimilars policy that encourages development of biosimilars, emphasizing the use of innovative technologies." Advantage, MNTA.
6) One potential downside for MNTA is mentioned, "Although additional animal and clinical studies will generally be needed for protein biosimilars for the foreseeable future, the scope and extent of such studies maybe be reduced further if extensive fingerprint-like characterization is used." I think it reasonable that if an overwhelming array of 'fingerprinting' has already been established, then these 'clinical studies' could certainly be limited to bioequivalence type human studies (as we have reason to believe MNTA is or has already conducted). I don't see this as an argument for large scale human efficacy trials -- but it might be read this way by some. Hard to interpret, but overall, potential advantage, TEVA.
7) Bad news for Teva's application and its immunogenicity problems with their Italian knock-off lovenox application: "Immunogencity remains a critical factor when assessing biosimilarity . . ." As noted by CW, findings of differences here point to absolutely fundamental differences -- and so fundamental bio-dis-similarity. Advantage: MNTA.
8) Lastly, they hold out as the gold standard, a step that MNTA has already uniquely achieved. ". . . Under the BPCI act, biosimilars will also have the opoportunity to meet a higher standard of similarity to a reference product -- 'interchangeability,' reflecting an FDA assessment that pharmacists can make substitutions between biologics without the subscriber's intervention." Clearly, advantage, MNTA.
Overall, that this body is so clearly aligned in though and philosophy with team MNTA I can not see as other that hugely encouraging. In short, smart people doing meticulously careful work are ones they like. MNTA's percentage will be further increasing in my portfolio.
Best,
MTB.
