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Post by mnholdem on Oct 20, 2015 8:37:46 GMT -5
How does one explain that EMA also lists Sanofi's Insuman(R) as a biosimilar? The EMA's rational for assigning the term "biosimilar" is when an applicant submits a drug for authorization where both the API and the delivery system have been approved before.
Insulin human is a decades-old API, but as far as the delivery system? There is a precedence: Exubera was approved by the EMA, even though they are no longer authorized.
Source: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000588/WC500054632.pdf
If the EMA considers Afrezza to be a 2nd drug where the API=insulin human and the API is delivered by inhalation, than it's feasible that the biosimilar label could be applied. 
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Post by xoxoxoxo on Oct 20, 2015 9:08:11 GMT -5
I don't think we want our delivery system to be lumped in with Exubera. But that's an interesting point.
However, technosphere hasn't been approved as the delivery mechanism in the past so I don't think you're correct. In the future after Afrezza is approved and we start submitting new drugs with generic APIs. Maybe our approval will be easy since that will just require the biosimilar process
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Post by mnholdem on Oct 20, 2015 9:21:43 GMT -5
True. I think Hakan stated that speed of approval was one of the criteria for determining future pipeline drugs.
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Post by bill on Oct 20, 2015 9:43:15 GMT -5
Given everything said to date, if Afrezza isn't what's on the agenda for today are we then saying that the EU approval process hasn't even been started? Could SNY have a global launch plan for Afrezza without even having started the EU approval process? I'm thinking this has to be Afrezza because it should be somewhere in the EU approval process, and this seems to be the only possibility. So many questions, so few answers.  |
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Post by rockstarrick on Oct 20, 2015 10:29:02 GMT -5
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Post by Deleted on Oct 20, 2015 10:39:36 GMT -5
the document is prescribing outlook.. sort of giving heads up details to prescribers? and not related to approvals? still says in P3 trial phase |
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Post by peppy on Oct 20, 2015 10:46:34 GMT -5
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Post by rockstarrick on Oct 20, 2015 10:47:17 GMT -5
There are two bio similar insulin products also listed on this same link, here they are. maybe the discussion today is about one of these 2 Insulin glargine injection [Abasria]; Eli Lilly Pharmacology: As for reference product – Lantus. Given by s.c. injection. Diabetes mellitus, type 1 and 2, adults, adolescents and children aged 2 years and above. Current status: Recommended for approval June 2014. UK availability: 2014 (Lantus patent expiry November 2014). Population: As for reference product. Primary care. Implications: Therapeutic equivalence to Lantus demonstrated. It is unclear what presentations will be available. Likely to be cheaper than Lantus. HRG included. PIII studies vs. Lantus have been completed: ELEMENT 1 in 550 adults with type 1 diabetes used in combination with insulin lispro and ELEMENT 2 in 606 adults with type 2 diabetes used with oral hypoglycaemics. In comparative studies adverse events and immunogenicity profile was similar for Abasria and Lantus. None specific to this product. Insulin glargine MK-1293 injection; Biogen Idec Pharmacology: As for reference product – Lantus. Given by s.c. injection. Diabetes mellitus, type 1 and 2. Current status: PIII UK availability: 2016 (Lantus patent expiry November 2014). Primary care. HRG included. None specific to this product. |
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Post by dreamboatcruise on Oct 20, 2015 10:48:46 GMT -5
Given everything said to date, if Afrezza isn't what's on the agenda for today are we then saying that the EU approval process hasn't even been started? Could SNY have a global launch plan for Afrezza without even having started the EU approval process? I'm thinking this has to be Afrezza because it should be somewhere in the EU approval process, and this seems to be the only possibility. So many questions, so few answers. As noted on the page at nhs.uk, it is still in trials. I believe this is the clamp study we all know about. Then it would start its way through those final approval steps. I wouldn't characterize that as "EU approval process hasn't even been started", but it isn't a biosimilar, so it would seem it can't be what's on the agenda for that meeting. |
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Post by rockstarrick on Oct 20, 2015 10:59:28 GMT -5
This is a list of new drugs submitted in the UK in 2014, for what reason, I don't know. if you look at the same list for 2015, Afrezza is still listed,(by name) but Toujeo is gone, it was approved so it was removed. this makes me think this list has something to do with approval. For Afrezza it does say p3 trials, approved in USA in 2014, but Afrezza was added to this list by Sanofi in 2014. My point is....... Sanofi has been working towards approval in other countries since 2014, prequisites I guess. |
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Post by rockstarrick on Oct 20, 2015 11:03:09 GMT -5
Given everything said to date, if Afrezza isn't what's on the agenda for today are we then saying that the EU approval process hasn't even been started? Could SNY have a global launch plan for Afrezza without even having started the EU approval process? I'm thinking this has to be Afrezza because it should be somewhere in the EU approval process, and this seems to be the only possibility. So many questions, so few answers. As noted on the page at nhs.uk, it is still in trials. I believe this is the clamp study we all know about. Then it would start its way through those final approval steps. I wouldn't characterize that as "EU approval process hasn't even been started", but it isn't a biosimilar, so it would seem it can't be what's on the agenda for that meeting. I would say you are correct after finding the bio similar section around p 75. probably the Lilly insulin. still good to see Afrezza on the UK list since 2014. good luck |
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Post by rockstarrick on Oct 20, 2015 11:21:21 GMT -5
This is a list of new drugs submitted in the UK in 2014, for what reason, I don't know. if you look at the same list for 2015, Afrezza is still listed,(by name) but Toujeo is gone, it was approved so it was removed. this makes me think this list has something to do with approval. For Afrezza it does say p3 trials, approved in USA in 2014, but Afrezza was added to this list by Sanofi in 2014. My point is....... Sanofi has been working towards approval in other countries since 2014, prequisites I guess. Last paragraph of screencast #3 says a lot. many of the drugs on this list are not available, but are listed so the commissioner and providers can  ?? Before launch. the list is for Agency's and Providers to establish cost ?? Before launch. what are your thoughts Peppy Thanks |
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Post by peppy on Oct 20, 2015 11:37:12 GMT -5
screencast.com/t/AJnWcDhtI think sanofi is working on approvals. Sanofi needs afrezza. They lost patent status on Lantus? and introduced toujeo new and improved? ---------------------------------------------------------------------------------------------------------------- on a different note (Sanofi owns regeneron correct? This unknowing person guessing regeneron may need technosphere.)
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Post by dreamboatcruise on Oct 20, 2015 11:38:32 GMT -5
Here is another paragraph that might have significance. Attachment DeletedWould seem there is a mechanism for a drug company to ask for a high price if the price is outcome based. I know nothing about this "NICE" list or "PAS" so perhaps it wouldn't be applicable to Afrezza, but imagine if SNY could ask for the same pricing as the U.S. based on lower hypos for a given A1c reduction... or perhaps slowing/stopping progression compared to orals. If they were willing to take that bet and have pricing be outcome based, might it preempt need for additional clinical trials to prove superiority... make it cheaper than Novolog/Humalog if it doesn't work any better but more expensive if it does. I'm guessing it isn't that simple. |
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Post by rockstarrick on Oct 20, 2015 11:51:23 GMT -5
Drugs listed but not available are listed so Commissioners and Providers can establish cost before LAUNCH.
So, Commisioners and Providers have been discussing Afrezza for a while now.
Things that mane you go hmmm.
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?? Before launch.