FDA 505(b)(2) Applications Seminar Part IV: The Thin Line between a 505(j) and 505(b)(2)



I also wanted to talk about the thin I don't the thin line between complex generics and the 505 B 2 applications I know I am wondering what happened here it looked it looked better in computer so when is a 505 B 2 a viable alternative to an anda so we are seeing that you know a lot of people have started thinking of 505 B 2 as an alternative to and as the reason is because the generic market has become super competitive and the way things are going if you are not the first or second company to get the drug approved you hardly make any profit so people have started thinking could we go to a 505 B 2 and then get an authorized generic when is it a viable alternative so you know reformulation of the product to address you know may be a different route of administration different population use of a different salt as I said we are seeing that quite often overcome you know the formulation design especially the q1 q2 this is one of the biggest fields where I'm we have seen even in FDA and out here in Perak cell where people have gone into the 505 B 2 because the q1 cuticle the being upon it quantitatively and qualitatively similar to the innovator product sometimes is becoming very difficult because of pattern challenges and other issues and they as I was just explaining that you know they might say that we can make a better formulation drug device combinations this is also one of the fields as we said we see that specially with the inhalation products we are seeing this a lot because you know the many of these devices are heavily patented and it's extremely difficult to get you know get a the patterns of people are saying why don't I go for a 505 B to complex peptides which our DNA our DNA sourced and include potential immunogenicity con concerns this is kind of a very gray area but we are seeing this as I was saying with many you know many of the complex genetics FDA came and told the world that we are opening our doors you know they they approved Salman calcitonin clarity tumour you know heparin low molecular weight heparin and that that gave the industry and impression that okay the doors are open and OGD is ready to look at complex generics but appears that they are kind of pulling themselves back on this and they are saying that if if a prote peptide is synthetic you know we are going to look at it but the moment it is an our DNA source there may be monotonicity concerns which technically becomes safety concerns so we are going to send them for five or five b2 and this is a become a very gray area because the question is many of these formulations are q-1 q-2 so you know how how and where they will fit is still to be seen but this is one issue that's coming the 505 b2 may help subverting some patent challenge the word is some here because even even if you are anything remotely close to the innovator you will get sued here a branded generic now the brand the word branded generic is aware is a term that we used to use in FDA this is a 505 B 2 but as I was saying if you have if you make a better formulation like for example exactly what I was saying that the general the innovator is a life alized powder in one bottle and buffer it has to be mixed and then it has to be given to the you know reconstituted in saline then given instead if you can find a way to stabilize that solution and you are bringing it's exactly the same strength and everything it may not be q1 q2 at the end of the day but once reconstituted it's more or less the same product so it's it's for all purposes are generic but technically can't be approved as a generic many of these get a 505 B 2 and then appeal and get what you call the AP or the a B rating mostly AP because it's parented we see this a lot in parentals not an easy pathway but we are seeing this a lot so why can a 505 B to be more more appealing obviously you're getting a three year marketing exclusivity depending on the nature of the 505 B 2 submission you know minimal amount of submission studies we have had situations where really you know hardly any kind of study or work was needed other than CMC lesser approval time than generic this is supposed to improve by with adieu for two because we do for one had created such a quagmire that it was taking 36 to 40 months for generics to be a proofs of b2 s became good options fast-track approval can be a guru for doesn't deal with orphan products they do not give any kind of priority but 505 b2 will remember better communication with FDA several meetings can be or at least very you know poignant written responses they are written respond they their communication is much more detailed and you get really good advice negotiation with FDA regarding studies less competition sometimes you know based on the nature of the product that you are bringing out and higher return on investment now obviously the last two could very big big time what are the challenges now remember that 505 b2 is an NDA it is nothing is assumed there so the fee for the NDA you know it's significantly higher you know gardulla is like what 73,000 now and this is six hundred plus thousand generic companies need to carefully in you know evaluate so not to jump into this you know and say let's just do it put a little thought on this so as we say that standard for demonstration of safety and efficacy is four and four NDA's are same at 505 b2 is an NDA significant studies including expensive clinical trials may be required the CMC requirement for 505 b2 can sometimes be different you know many things example of course this is probably the minimal like they need 12 months long-term stability versus six months for generics but we have also seen regarding excipients a lot of things are assumed in the office of generic drug but in when you go to the new drug you have to be careful so they also have to have a good idea of what currently marketed products you know and strategize because with generic the thought process in there isn't a lot of thought other than maybe how am I going to break the patent involved but here you need to really strategize so please remember that 505 b2 is not a glorified under there needs to be study of several candidates study of the market demands you know and the risks and roadblocks and we can't stress this enough please if you are planning a 505 B 2 even if it's at a conception stage to go for a meeting

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