Replies to post #196514 on Biotech Values

[DewDiligence]

US FoB factoids—FDA has acknowledged the existence of 57 programs using the 351(K) pathway pertaining to 16 reference products:

http://www.pharmexec.com/fda-looks-limit-clinical-trials-biosimilar-rd-0

[DewDiligence]

Cheat Sheet of Samsung Bioepis Partnerships with MRK/BIIB

Humira FoB
Partnered with BIIB in EU, Switzerland, Russia, Turkey; partnered with MRK in RoW (including US).

Enbrel FoB
Partnered with BIIB in EU, Switzerland, Japan; partnered with MRK in RoW excluding US. (Samsung has no Enbrel FoB program in US due to AMGN’s long-lasting US patent protection.)

Remicade FoB
Same breakdown of countries as Humira FoB.

Herceptin FoB
Partnered with MRK worldwide.

Lantus FoB
Partnered with MRK worldwide.

Source:
http://www.biosimilarnews.com/positive-phase-iii-outcomes-from-samsung-bioepis-biosimilar-candidates

[DewDiligence]

Announced FoB Collaborations

[Added “cheat sheet” for Samsung/MRK/BIIB partnership.]


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

 
                     Date   Targets   Geography     iHub References 
 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 
 BXLT-CHRS           9/13   Enbrel    ex-US         #msg-91645674 
 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-84781042,#msg-69629103 
 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 
 BXLT-MNTA          12/11   Humira    global        #msg-110925786 
 PFE(HSP)-Celltrion 10/09   z         global        #msg-84519981 
 MYL-Biocon          6/09   x         global        #msg-72421544,#msg-84561737 
 Procognia-UTR       n/a    Humira    unspecified   #msg-84340976 

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

@See #msg-118427495.

#Humira, Rituxan, Avastin, Herceptin.

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

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