Replies to post #160950 on Biotech Values

[DewDiligence]

PFE starts phase-1 trial of Humira biosimilar:

http://www.clinicaltrials.gov/ct2/show/NCT01870986

Thanks to ‘biosimilarz’ on Twitter for this find.

[DewDiligence]

NVS starts phase-3 trial of Enbrel FoB:

http://in.reuters.com/article/2013/06/24/us-novartis-enbrel-idINBRE95N05Y20130624

Given the IP protection for Enbrel in the US, which runs until 2028 (#msg-69263618), NVS’ FoB is presumably intended for ex-US markets only.

[DewDiligence]

EU approves first mAb biosimilars: HSP’s and Celltrion’s knockoffs of JNJ/MRK’s Remicade, which are called Remsima and Inflectra, respectively:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001837.jsp&mid=WC0b01ac058004d5c1

MRK has the commercial rights to Remicade in the EU, where it is patent-protected in some countries until 2014.

[DewDiligence]

Major FoB Collaborations

[Updated footnote re Celltrion/HSP and Remicade.]


Items are shown in reverse chronological order.

 
                    Date   Targets   Geography     iHub References 
 Oncobiolgcs-Huahai 5/13   #         global        #msg-87734336, #msg-87744882 
 Strides-Pfenex     4/13   Betaseron global        #msg-87014470 
 MRK-Samsng/BIIB    2/13   @         unspecified   #msg-84781042, #msg-69629103 
 Catalent-UMN      12/12   various   Asia          #msg-82556713 
 Merck KGaA-RDY     6/12   oncology  global        #msg-76359649 
 Daiichi-Coherus    5/12   *         Asia          #msg-75397629 
 Fujifilm-Kyowa     3/12   Humira    unspecified   #msg-73800486 
 ACT-Bioton         2/12   insulin   US & Europe   #msg-74987123 
 ACT-AMGN          12/11   †         global        #msg-70097496, #msg-84340328 
 BAX-MNTA          12/11   ‡         global        #msg-70212854, #msg-70258421 
 HSP-Celltrion     10/09   z         global        #msg-84519981, #msg-77816122 
 MYL-Biocon         6/09   x         global        #msg-72421544, #msg-84561737 
 Procognia-UTR      n/a    Humira    unspecified   #msg-84340976 

*Enbrel and Rituxan.

†Humira, Remicade, Herceptin, Avastin, Rituxan, Erbitux; excludes AMGN FoB’s for AMGN’s branded drugs.

‡Three products in development: 2 auto-immune and 1 oncology—my guesses are Humira, Orenica, Erbitux; may include up to 6 products eventually.

@ Samsung/BIIB subordinate collaboration known as Samsung Bioepis; Rituxan program terminated (#msg-80622249); presumably excludes FoB’s for BIIB’s branded drugs.

#Humira, Rituxan, Avastin, Herceptin.

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

y Rituxan program terminated (#msg-80236315); status of other programs unknown.

z Each company received a distinct EU/CHMP approval for Remicade on 6/28/13; partnership includes seven (other) products: Rituxan, Herceptin, Enbrel, Erbitux, Synagis, Humira, Avastin.