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Post by mnholdem on Dec 12, 2017 9:03:45 GMT -5
FDA Approves Sanofi's Admelog® (insulin lispro injection)
* First FDA-approved follow-on mealtime insulin
* Admelog (insulin lispro injection) 100 Units/mL will be available in U.S. in vial and SoloStar pen
[11-December-2017]
PARIS, Dec. 11, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime.
"Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes."
Admelog is a rapid-acting insulin similar to Humalog®, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S.
Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi®, by the European Commission in July 2017.
Source: www.biospace.com/article/releases/fda-approves-sanofi-s-admelog-the-first-follow-on-insulin-to-control-sugar-at-mealtime/
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MnHoldem's Comment: There's been no indication yet what the price of Sanofi's biosimilar insulin lispro will be, but I imagine that Sanofi will have little problem getting insurance coverage, which will put pressure on Novo, Lilly and MannKind to lower the prices of their mealtime insulin brands.
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Post by digger on Dec 15, 2017 7:12:25 GMT -5
That doesn't make much sense to me. They have apidra, so why the biosimilar? I don't imagine there's much difference in cost to manufacture.
Why not simply price apidra lower? It wouldn't affect apidra revenues much since they are relatively non-existent as it is.
I would bet the contrary as to insurance coverage. Lilly and Novo appear to have worked out deals that practically give them a lock on top tier placement. I don't see what Sanofi could do with a biosimialr that it couldn't do with apidra.
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Post by mnholdem on Dec 15, 2017 7:27:20 GMT -5
Of Apidra, Humalog and Novolog, Apidra arguably has the best PK/PD of the three RAA insulin brands, yet Apidra sales are dismal:
24 Nov 2017*
Afrezza 360 $426k 199 $217k
Apidra 2616 $1.9m 842 $635k
Novalog 121k $110m 45k $42.5m
Humalog 122k $117m 45k $461m
*full data —
OOG (otherottawaguy ) December 12, 2017
Since Sanofi doesn't have much to lose in the prandial insulin market, its Novolog biosimilar could generate significant revenue for the company in a current environment where pharmaceutical companies are taking heat for the prices being charged for life-saving insulin. |
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Post by agedhippie on Dec 15, 2017 8:28:28 GMT -5
That doesn't make much sense to me. They have apidra, so why the biosimilar? I don't imagine there's much difference in cost to manufacture. Why not simply price apidra lower? It wouldn't affect apidra revenues much since they are relatively non-existent as it is. I would bet the contrary as to insurance coverage. Lilly and Novo appear to have worked out deals that practically give them a lock on top tier placement. I don't see what Sanofi could do with a biosimialr that it couldn't do with apidra. It's a biosimilar so they can pitch the price below Apidra and potentially build bundles to compete with Lilly and Novo. Sanofi still has the biggest chunk of the basal analog insulin market which they could leverage. |
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Post by sayhey24 on Dec 15, 2017 12:25:42 GMT -5
That doesn't make much sense to me. They have apidra, so why the biosimilar? I don't imagine there's much difference in cost to manufacture. Why not simply price apidra lower? It wouldn't affect apidra revenues much since they are relatively non-existent as it is. I would bet the contrary as to insurance coverage. Lilly and Novo appear to have worked out deals that practically give them a lock on top tier placement. I don't see what Sanofi could do with a biosimialr that it couldn't do with apidra. It's a biosimilar so they can pitch the price below Apidra and potentially build bundles to compete with Lilly and Novo. Sanofi still has the biggest chunk of the basal analog insulin market which they could leverage. Why not just cut the price of Aprida which has a better pk/pd profile? Why incur the expense of building a new manufacturing facility to compete against yourself? If they cut the price of Aprida in half maybe they could be doing 200k scripts a week. What am I not getting? |
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Post by agedhippie on Dec 16, 2017 9:11:30 GMT -5
It's a biosimilar so they can pitch the price below Apidra and potentially build bundles to compete with Lilly and Novo. Sanofi still has the biggest chunk of the basal analog insulin market which they could leverage. Why not just cut the price of Aprida which has a better pk/pd profile? Why incur the expense of building a new manufacturing facility to compete against yourself? If they cut the price of Aprida in half maybe they could be doing 200k scripts a week. What am I not getting? A biosimilar can step into the original's shoes so it avoids all the messy DTC marketing. For the insurer it's simply a 1:1 swap in the formulary that returns an immediate lower cost. Sanofi are just following the line of least resistance into a 140k scripts per week market. It's a reasonable question on Apidra. I think they see it as a niche drug at this point so there is no point in dropping the price.I also wonder what the margin is on Apidra. It could be that they are concerned that an insurer would force down the pricve of their other drugs as part of the deal and would rather not open that box. |
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Post by dreamboatcruise on Dec 16, 2017 17:31:31 GMT -5
I would assume that a key aspect of the business proposition is that a biosimilar is treated like a generic. Sanofi wouldn't have to convince doctors to write scripts for their version, it could simply be swapped for Humalog at the pharmacy level and if they strike deals for better placement on a formulary a patient would get to the pharmacy and be told "you can pay $50 for Humalog or get this equivalent one for $20". At least I think this is how biosimilars are treated.
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