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[行业反思] 公开曝光能阻止原研药公司滥用系统/体制阻碍仿制药厂家获取参比制剂吗??

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药士
发表于 2018-5-18 17:13:50 | 显示全部楼层 |阅读模式

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本帖最后由 beiwei5du 于 2018-5-18 17:19 编辑

Will Public Shaming Stop the Gaming of the System?

By Bob Pollock | May 17, 2018 | Compliance, FDA, Generics, Regulatory Affairs | Like |


Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval.  The FDA has taken this extraordinary approach to provide greater transparency regarding this issue.  If ANDA sponsors cannot obtain samples to conduct BE testing, they cannot obtain ANDA approvals, which in turn limits competition and, as a result, adversely impacts drug prices.
FDA describes two scenarios where the gaming occurs:
  • Where there is a restricted distribution system for the innovator products
  • Where there is a REMS program in place that contains Elements to Assure Safe Use (ETASU)
The FDA announcement of the program (here) discusses how the process works in both scenarios and, most importantly, dispels the notion that there is a potential safety problem if applicants run BE tests on the specific products, as has been posited by certain people (see one example previously posted here). The FDA reviews all protocols for REMS products with ETASUs to assure that the same safety elements and protection for the subjects in the BE studies are comparable to those for patients taking the innovator drug.  The FDA further notes that it will only allow the study to proceed if the firm has met all of its requirements and responds to any comments the FDA makes upon reviewing the initial protocol.
The FDA lists 52 different products for which it has received 164 individual requests.  The top four products for which requests had been received are:
Tracleer                14
Revlimid               13
Thalomid             10
Letairis                  10
The FDA also identifies the company that is the innovator in its list; however, the Agency does not outline which (if any) requests have been fulfilled by the innovator.
Only time will tell if the list will have any impact on opening the way for ANDA sponsors to obtain the required samples for BE testing, but it certainly provides the public with a window into the magnitude of the problem.



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药士
 楼主| 发表于 2018-5-18 17:16:44 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-5-18 17:18 编辑


RLD Access Inquiries
Product
RLD Sponsor3
Number of Inquiries Received by FDA
Does the product have a REMS with ETASU Impacting Distribution?
For Products with REMS with ETASU Impacting Distribution: Date(s) of Safety Determination Letter(s) Issued (if applicable)
Absorica (isotretinoin)
RANBAXY INC/SUN PHARMACEUTICAL INDUSTRIES INC
5
Yes
12/9/2015
Abstral (fentanyl citrate)
GALENA BIOPHARMA
1
Yes

Accutane (isotretinoin)
ROCHE PALO ALTO LLC
2
Yes
6/23/2009
Adempas (riociguat)
BAYER HEALTHCARE PHARMACEUTICALS INC
2
Yes
9/27/2016; 5/2/2017
Afinitor (everolimus)
NOVARTIS PHARMACEUTICALS CORP
1
No
N/A
Amnesteem (isotretinoin)
MYLAN PHARMACEUTICALS INC
3
Yes

Ampyra (dalfampridine)
ACORDA THERAPEUTICS INC
4
No
N/A
Brilinta (ticagrelor)
ASTRAZENECA LP
1
No
N/A
Claravis (isotretinoin)
TEVA PHARMACEUTICALS USA
4
Yes

Clozaril (clozapine)
HERITAGE LIFE SCIENCES BARBADOS INC
1
Yes

Cystadane (betaine hydrochloride)
ORPHAN EUROPE SARL
1
No
N/A
Embeda (morphine sulfate; naltrexone hydrochloride)
ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS
1
No
N/A
Entereg (alvimopan)
CUBIST PHARMACEUTICALS INC
5
Yes

Exjade (deferasirox)
NOVARTIS PHARMACEUTICALS CORP
6
No
N/A
Fazaclo ODT (clozapine)
JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
1
Yes

Fentora (fentanyl citrate)
CEPHALON INC
1
Yes

Ferriprox (deferiprone)
APOPHARMA INC
1
No
N/A
Firazyr (icatibant acetate)
SHIRE ORPHAN THERAPIES INC
2
No
N/A
Gattex Kit (teduglutide recombinant)
NPS PHARMACEUTICALS INC
1
No
N/A
Gilotrif (afatinib dimaleate)
BOEHRINGER INGELHEIM
1
No
N/A
H.P. Acthar Gel (corticotropin)
QUESTCOR PHARMACEUTICALS INC
2
No
N/A
Hemabate (carboprost tromethamine)
PHARMACIA AND UPJOHN CO
1
No
N/A
Juxtapid (lomitapide mesylate)
AEGERION PHARMACEUTICALS INC
3
Yes

Korlym (mifepristone)
CORCEPT THERAPEUTICS INC
1
No
N/A
Kuvan (sapropterin dihydrochloride)
BIOMARIN PHARMACEUTICAL INC
3
No
N/A
Letairis (ambrisentan)
GILEAD SCIENCES INC
10
Yes
9/1/2015; 7/5/2016
Methadone Hydrochloride (methadone hydrochloride)
ROXANE LABORATORIES INC
1
No
N/A
Mifeprex (mifepristone)
DANCO LABORATORIES LLC
1
Yes

Nexavar (sorafenib tosylate)
BAYER HEALTHCARE PHARMACEUTICALS INC
2
No
N/A
Onsolis (fentanyl citrate)
MEDA PHARMACEUTICALS INC
1
Yes

Opsumit (macitentan)
ACTELION PHARMACEUTICALS LTD
8
Yes
7/5/2016; 12/8/2016; 4/23/2018
Orfadin (nitisinone)
SWEDISH ORPHAN BIOVITRUM AB PUBL
2
No
N/A
Pomalyst (pomalidomide)
CELGENE CORP
8
Yes

Promacta (eltrombopag olamine)
GLAXOSMITHKLINE
2
Yes

Promacta (eltrombopag olamine)
GLAXOSMITHKLINE
1
No
N/A
Qsymia (phentermine hydrochloride; topiramate)
VIVUS INC
8
Yes
8/13/2015
Ravicti (glycerol phenylbutyrate)
HYPERION THERAPEUTICS INC
1
No
N/A
Revlimid (lenalidomide)
CELGENE CORP
13
Yes
7/31/2012; 5/19/2014; 2/22/2017; 8/15/2017
Sabril (vigabatrin) for solution
LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC
3
Yes

Sabril (vigabatrin) tablet
LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC
4
Yes

Subsys (fentanyl)
INSYS THERAPEUTICS INC
2
Yes

Tasigna (nilotinib hydrochloride monohydrate)
NOVARTIS PHARMACEUTICALS CORP
3
No
N/A
Tecfidera (dimethyl fumarate)
BIOGEN IDEC INC
1
No
N/A
Thalomid (thalidomide)
CELGENE CORP
10
Yes
12/11/2007; 1/17/2008
Tikosyn (dofetilide)
PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
4
Yes

Tracleer (bosentan)
ACTELION PHARMACEUTICALS LTD
14
Yes
7/31/2013; 9/1/2015; 9/1/2015; 10/16/2015; 1/29/2016
Truvada (emtricitabine; tenofovir disoproxil fumarate)
GILEAD SCIENCES INC
1
No
N/A
Tykerb (lapatinib ditosylate)
SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
1
No
N/A
Veletri (epoprostenol sodium)
ACTELION PHARMACEUTICALS LTD
1
No
N/A
Xenazine (tetrabenazine)
VALEANT INTERNATIONAL BERMUDA/VALEANT PHARMACEUTICALS NORTH AMERICA LLC
4
No
N/A
Zavesca (miglustat)
ACTELION PHARMACEUTICALS LTD
3
No
N/A
Zortress (everolimus)
NOVARTIS PHARMACEUTICALS CORP
1
No
N/A

3 The RLD sponsor on this list is the RLD sponsor listed in the Orange Book at the time of inquiry. In some cases where FDA received more than one inquiry about a particular product, the listed RLD sponsor changed from one inquiry to the next – for example, if the product changed hands from one company to another. In such cases, the chart includes the names of the different listed RLD sponsors.

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药士
 楼主| 发表于 2018-5-18 17:20:50 | 显示全部楼层
CELGENE CORP新基是大头啊!
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药士
 楼主| 发表于 2018-5-18 18:11:07 | 显示全部楼层
也是只能是权宜之计啊,FDA没有强制执法权,也只能出一份safety determination letter给原研厂家或者将其推送给FTC(FTC依照反竞争相关程序进行调查),以及依靠这种“公开曝光”的措施来施加于舆论压力。
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