Replies to post #171435 on Biotech Values

[DewDiligence]

France permits automatic FoB substitution for new patients, the first EU country to do so:

http://www.gabionline.net/Policies-Legislation/France-to-allow-biosimilars-substitution

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological as long as the prescribing physician has not marked the prescription as ‘non-substitutable’.
The new law concerning the Social Security budget (Article 47 of the Law of 23 December 2013), which came into effect on 1 January 2014, has adapted provisions that allow the substitution of originators by generics to extend to biosimilars. Substitution of biosimilars is allowed only when initiating a course of treatment…

… France is the first European country to explicitly permit biosimilar substitution. In the European Union (EU), decisions on pharmacy substitution of medicines (whether generic or biosimilar) are made at the Member State level.

[DewDiligence]

Lupin, Yoshindo ink FoB collaboration for Japanese market; lead product candidate is Enbrel:

http://finance.yahoo.com/news/lupin-inks-strategic-joint-venture-144600240.html

Lupin Limited announced today that it has entered into a strategic joint venture agreement with…Japanese pharmaceuticals company, Yoshindo Inc. to create a new entity, YL Biologics (YLB). YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain Biosimilars including regulatory filings and obtaining marketing authorizations in Japan.

The new entity YLB will in-license Monoclonal Antibodies (mAbs) from Lupin and also partner with other companies across the globe for the Japanese market which already has a clear cut regulatory regime in place for the development and commercialization of Biologicals. Lupin's Etanercept biosimilar…will be the first product to be licensed for clinical development to YLB.

[DewDiligence]

Major FoB Collaborations

[Added entry for Lupin-Yoshindo.]


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

 
                    Date   Targets   Geography     iHub References 
 Lupin-Yoshindo     4/14   Enbrel+   Japan         #msg-101018361 
 BAX-Coherus        9/13   Enbrel    ex-US         #msg-91645674 
 Oncobiolgcs-Huahai 5/13   #         global        #msg-87734336,#msg-87744882 
 Strides-Pfenex     4/13   Betaseron global        #msg-87014470 
 MRK-Samsng/BIIB    2/13   @         Europe+       #msg-84781042,#msg-69629103,#msg-95065880 
 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 developing Remicade and Enbrel FoB’s in Europe (#msg-95065880); Rituxan program terminated (#msg-80622249).

#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.