Replies to post #200629 on Biotech Values

[DewDiligence]

FDA guidance documents wrt FoBs (Apr 2015):

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf

[DewDiligence]

AMGN, Daiichi Sankyo ink Japanese-commercialization deal for Humira/Avastin/Herceptin FoBs:

http://finance.yahoo.com/news/amgen-daiichi-sankyo-announce-agreement-010000498.html

Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan, while Amgen will have a limited right to co-promote the products.

…Specific financial terms of the agreement were not disclosed.

AMGN has a pre-existing worldwide (ex-Japan) partnership with AGN (formerly Watson) to develop FoBs for Avastin, Rituxan, Herceptin, and Erbitux (#msg-70097496), and AMGN is developing (ex-Japan) FoBs on its own for Humira (#msg-123830467) and Remicade.

[DewDiligence]

FoB Collaborations

[Deleted BXLT deals with CHRS and MNTA;
added Daiichi-AMGN deal for Japan.]


Items are shown in reverse chronological order. This table does not purport to be exhaustive.

 
                     Date   Targets   Geography     iHub References 
 Daiichi-AMGN        7/16   y         Japan         #msg-123859411 
 MYL-MNTA            1/16   ‡         global        #msg-119689602 
 AZN-Fujifilm/Kyowa  7/15   Avastin   global        #msg-115666552 
 PFE(HSP)-PFNX       2/15   Lucentis  global        #msg-110725481 
 Merck KGaA-Hanwha   2/15   Enbrel    ex-US         #msg-110668714 
 EPRS-Livzon         9/14   5 mAbs    China         #msg-106600322 
 NeuClone-Serum Inst 7/14   10 mAbs   global        #msg-104136710 
 Liomont-Oncobiolgcs 6/14   2 mAbs    Mexico        #msg-103754486 
 PlantForm-PhrmaPrxs 6/14   Avastin   Brazil        #msg-103576633 
 Lupin-Yoshindo      4/14   Enbrel    Japan         #msg-101018361 
 EPRS-Ranbaxy        1/14   Remicade  Asia/Africa   #msg-95745192 
 Oncobiolgcs-Huahai  5/13   #         global        #msg-87734336,#msg-87744882 
 Strides-Pfenex      4/13   Betaseron global        #msg-87014470 
 Samsung/MRK/BIIB    2/13   @         @             #msg-118427495,#msg-119900027,#msg-118426909 
 Catalent-UMN       12/12   various   Asia          #msg-82556713 
 Merck KGaA-RDY      6/12   oncology  global        #msg-76359649 
 Daiichi-CHRS        5/12   Enbrel    Asia          #msg-75397629 
 Fujifilm-Kyowa      3/12   Humira    unspecified   #msg-73800486 
 AGN-Bioton          2/12   insulin   US & Europe   #msg-74987123 
 AGN-AMGN           12/11   †         global        #msg-70097496,#msg-117190738 
 PFE(HSP)-Celltrion 10/09   z         global        #msg-42334655,#msg-121701314,#msg-84519981 
 MYL-Biocon          6/09   x         global        #msg-72421544,#msg-84561737 
 Procognia-UTR       n/a    Humira    unspecified   #msg-84340976 

‡ Orencia and five undisclosed compounds.

@ See #msg-118427495.

† Herceptin, Avastin, Rituxan, Erbitux; AMGN working independently on Humira and Remicade.

# Humira, Rituxan, Avastin, Herceptin.

x Nine products: Herceptin, Neulasta, Avastin, Humira, Enbrel, Lantus, Novolog, Humalog, one undisclosed.

y Humira, Avastin, Herceptin.

z Remicade (approved in EU), Enbrel, Erbitux, Synagis, Humira, Avastin; Riruxan and Herceptin returned to Celltrion in 9/15.