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Post by peppy on Oct 19, 2015 11:01:49 GMT -5
any truth to this?
the agenda for the CHMP evaluation meeting 19-22 Oct is out
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Pre authorisation process : Insulin Human (003858) : oral explanation given tomorrow 10/20
I tried going through search and got lost looking at the link. I saw insulin, technosphere I did not see.
2.1.1. - insulin human - EMEA/H/C/003858
treatment of diabetes
Scope: Oral explanation
Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00.
List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
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Post by cathode on Oct 19, 2015 11:27:55 GMT -5
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Post by peppy on Oct 19, 2015 11:38:15 GMT -5
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Post by mnholdem on Oct 19, 2015 11:44:07 GMT -5
You won't find Technosphere mentioned anywhere in this Case No. 003858 for what is believed to be Centralised Authorization to Market this insulin in the EU. In the minutes of the July meeting of the CHMP, the applicant's request to extend the clock-stop (deadline) to respond to the 180-day outstanding issues was granted.
From minutes of 20-23 July 2015 meeting:
3.4. Update on on-going initial applications for Centralised procedure
3.4.1. insulin human - EMEA/H/C/003858
treatment of diabetes
Scope: Request for an extension of clock stop
Action: For adoption
Day 180 list of outstanding issues adopted 25.06.2015. List of Questions adopted on 23.10.2014.
The CHMP noted the request from the applicant for an extension of clock-stop to respond to Day 180 list of outstanding issues. The Committee discussed this request and agreed for extension to the clock stop with a specific timetable.
Apparently, the applicant is now ready to address those issues.
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Some people think this application is for Afrezza and that Sanofi has been granted anonymity by the EMA. If so, the decision to authorize will be made within 45 days, if no issues remain unresolved. There are many people who think that this EMA case is NOT related to Afrezza (such as the use of "biosimilar" in describing the drug) but I think we should be able to put the debate to bed soon.
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Post by cathode on Oct 19, 2015 11:44:43 GMT -5
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Post by peppy on Oct 19, 2015 11:46:41 GMT -5
Thank you mn. I sure couldn't figure it out. thank you cathode.
Back to, it is nice seeing price going up.
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Post by lakers on Oct 19, 2015 11:47:21 GMT -5
2.1.1. - insulin human - EMEA/H/C/003858
treatment of diabetes
Scope: Oral explanation
Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00.
List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
BWP Report Less
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Post by lakers on Oct 19, 2015 11:48:17 GMT -5
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Post by rockstarrick on Oct 19, 2015 11:57:44 GMT -5
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Post by rockstarrick on Oct 19, 2015 12:44:01 GMT -5
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Post by peppy on Oct 19, 2015 14:12:23 GMT -5
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Post by dreamboatcruise on Oct 19, 2015 14:58:50 GMT -5
For what it's worth I highly doubt it would be listed as biosimilar if it were Afrezza. The insulin itself may be biosimilar to existing insulin, but when it is combined with Technosphere for inhalation it is no longer biosimilar to anything on the market.
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Post by Chris-C on Oct 19, 2015 19:27:25 GMT -5
For what it's worth I highly doubt it would be listed as biosimilar if it were Afrezza. The insulin itself may be biosimilar to existing insulin, but when it is combined with Technosphere for inhalation it is no longer biosimilar to anything on the market. DBC I agree. This August post from Dean provides a perspective on how the EMA process works in a manner that makes it unlikely that the current EMA agenda item is about Afrezza. It seems highly relevant to this thread. Regards Chris C (With thanks to Harryx1 for locating it in the board "archives". |
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Post by xoxoxoxo on Oct 19, 2015 19:59:35 GMT -5
Last time this came up, I posted this link which mentions the Human Insulin being reviewed by the EMA as Insuman. www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-April-2015I still haven't seen a decent argument why it would be Afrezza. I've also read through the new rules the EMA published specific to biosimilar insulins. It's specific to subQ/injected insulins. There's no way Afrezza would qualify under their biosimilar rules as a biosimilar. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdfAs much as I like the speculation, as a long I think this type of pumping hurts us. The pumpers build expectation and the stock gets crushed when it doesn't come to fruition. I put the EMA surprise approval posts in the same category as the "MNKD is about to be bought out by $20/share" posts. Note: If you consider this soft bashing, then holy cow, read the EMA guidelines and show me where I'm wrong please. |
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Post by mbracket1234 on Oct 19, 2015 20:29:27 GMT -5
You are correct, it is not Afrezza - it is for a biosimilar which Afrezza is not.
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