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US BLA Tracker (Last Updated May 8, 2015)

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US BLA Tracker (Last Updated May 8, 2015) US BLA Tracker (last updated May 8, 2015) Brand Product Brand BLA Applicant BLA Name Status Court & Regulatory Dockets Sponsor Pfizer, Inc. PF-05280586 In Phase 1 clinical trials.1 Avastin® Genentech, Actavis PLC / ABP 215 In Phase 3 clinical trials.2,3 (bevacizumab) Inc. Amgen, Inc. Sandoz / Novartis secukinumab In Phase 3 clinical trials.4 3:13-cv-2904 (NDCA) AG 2014-1693 (CAFC) Enbrel ® Merck HD203 Amgen, Inc. (etanercept) Sambsung Bioepis SB4 In Phase 3 clinical trials.5 MAA validated for review by the EMA. Coherus CHS-0214 In Phase 3 clinical trials.6 Epogen® / Amgen, Inc. Hospira Retacrit® Application submitted on December Procrit® / Janssen (SB309) 16, 2014.7 (epoetin alfa) Biotech, Inc. Erbitux® Bristol Actavis PLC / ABP 94 Stage of development unspecified.8 (cetuximab) Myers Amgen, Inc. Squibb / Eli Lilly & Co. Herceptin® Genentech, Pfizer, Inc. PF-05280014 In Phase 3 clinical trials.9 (trastuzumab) Inc. Actavis PLC / ABP 980 In Phase 3 clinical trials.10,11 1 Pfizer Pipeline, as of February 27, 2015 (http://www.pfizer.com/sites/default/files/product-pipeline/February_27_2015_Pipeline_Update_Final2.pdf) 2 February 18, 2015 “Actavis Outlines Standalone Pharmaceutical Pipeline at Investor Meeting” http://www.actavis.com/news/news/thomson-reuters/actavis- outlines-standalone-pharmaceutical-pipelin 3 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 4 http://www.novartis.com/downloads/newsroom/corporate-fact-sheet/4a_Sandoz_EN.pdf 5 Samsung Bioepis Biosimilar Pipeline; Accessed March 9, 2015; http://www.samsungbioepis.com/ 6 http://www.coherus.com/press-releases/coherus-announces-initiation-of-phase-3-trial-of-chs-0214-investigational-etanercept-biosimilar-in-chronic-plaque- psoriasis-rapsody/ 7 http://phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irol-newsArticle&ID=2006860 8 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 9 Pfizer Pipeline, as of February 27, 2015 (http://www.pfizer.com/sites/default/files/product-pipeline/February_27_2015_Pipeline_Update_Final2.pdf) 50356338.1 Amgen, Inc. Samsung Bioepis / SB3 (MK- In Phase 3 clinical trials.12 Merck & Co. 1293) Mylan / Biocon Launched in India; In Phase 3 clinical trial.13 Amgen, Inc. ABP501 Completed Phase 3 clinical trials in FDA-2012-P-0317-0001 plaque psoriasis and rheumatoid arthritis. 14 Samsung Bioepis SB5 In Phase 3 clinical trials.15 FDA-2012-P-0317-0001 Sandoz / Novartis In Phase 3 clinical trials.16 FDA-2012-P-0317-0001 AG Pfizer, Inc. PF-06438179 In Phase 1 clinical trials.17 FDA-2012-P-0317-0001 Humira® AbbVie Momenta M923 In Phase 3 clinical trials.18 FDA-2012-P-0317-0001 (adalimumab) Pharmaceuticals/ Baxter International Oncobiologics ONS-3010 In Phase 3 clinical trials.19 FDA-2012-P-0317-0001 Zydus Cadila Exemptia Launched in India20; U.S. regulatory FDA-2012-P-0317-0001 approval projected for 2019.21 Epirus BOW015 Launched in India; U.S. regulatory Biopharmacueticals approval projected for 2017.22 10 February 18, 2015 “Actavis Outlines Standalone Pharmaceutical Pipeline at Investor Meeting” http://www.actavis.com/news/news/thomson- reuters/actavis-outlines-standalone-pharmaceutical-pipelin 11 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 12 Samsung Bioepis Biosimilar Pipeline; Accessed March 9, 2015; http://www.samsungbioepis.com/ 13 https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001965-42/LV 14 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 15 Samsung Bioepis Biosimilar Pipeline; Accessed March 9, 2015; http://www.samsungbioepis.com/ 16 http://www.novartis.com/newsroom/media-releases/en/2013/1750954.shtml 17 Pfizer Pipeline, as of February 27, 2015 (http://www.pfizer.com/sites/default/files/product-pipeline/February_27_2015_Pipeline_Update_Final2.pdf) 18 http://ir.momentapharma.com/releasedetail.cfm?releaseid=885298 19 Oncobiologics Biosimilars Product Pipeline; accessed March 9, 2015 http://oncobiologics.com/as_biosimilars-pipeline 20 http://www.zyduscadila.com/press/PressNote09-12-14.pdf 21 http://seekingalpha.com/news/2167525-humira-biosimilar-launched-in-india 22 http://www.epirusbiopharma.com/pipeline/overview.php 50356338.1 Coherus CHS-1420 In Phase 1 clinical trials.23 Lantus® Mylan In Phase 3 clinical trials. 24,25 Sanofi S.A. (Insulin Glargin) Samsung Bioepis SB9 In Phase 3 clinical trials.26 Apotex Corp. Accepted for filing on December 17, Neulasta® 2014. Pending FDA review.27 Amgen, Inc. (pegfilgrastim) Sandoz / Novartis Phase 3 clinical trials for global AG registration completed.28 Sandoz / Novartis Zarxio® Approved. Sandoz’s agreement not to 3:14-cv-4741 (NDCA) AG launch until 5/11/15 is currently halted FDA-2014-P-1771 by Federal Circuit temporary injunction against Zarxio. 29 Federal Circuit Neupogen® hearing regarding the injunction is Amgen, Inc. (filgrastim) scheduled for 6/3/2015—decision by the end of July or early August is expected. Apotex Grastofil™ Accepted for filing on February 14, 2015. Pending FDA review.30 Orencia® Bristol- Momenta M834 (abatacept) Myers Pharmaceuticals Squibb Celltrion / Hospira Remsima® Accepted for filing. Pending FDA 1:14-cv-11613 (DMA) Remicade® Janssen (CT-P13) review.31 Approved in Europe. 1:15-cv-10698 (DMA) (infliximab) Biotech, Inc. Pfizer, Inc. PF-06410293 In Phase 3 clinical trials.32 23http://www.coherus.com/press-releases/coherus-announces-chs-1420-investigational-adalimumab-biosimilar-meets-primary-endpoint-in-pivotal- pharmacokinetic-clinical-study/ 24 https://clinicaltrials.gov/ct2/show/NCT02227862 25 https://clinicaltrials.gov/ct2/show/NCT02227875 26 Samsung Bioepis Biosimilar Pipeline; Accessed March 9, 2015; http://www.samsungbioepis.com/ 27 http://www.apotex.com/global/about/press/20141217.asp 28 http://www.novartis.com/downloads/newsroom/corporate-fact-sheet/4a_Sandoz_EN.pdf 29 http://orangebookblog.typepad.com/files/order-3.pdf 30 http://www.apotex.com/global/about/press/20150217-2.asp 31 http://www.celltrion.com/en/company/notice_view.asp?idx=456&code=ennews&intNowPage=1&menu_num=&align_year=all 32 Pfizer Pipeline, as of February 27, 2015 (http://www.pfizer.com/sites/default/files/product-pipeline/February_27_2015_Pipeline_Update_Final2.pdf) 50356338.1 Samsung Bioepis SB2 In Phase 3 clinical trials.33 MAA validated for review by the EMA.34 Amgen, Inc. ABP 710 Stage of development unspecified.35 Nippon Kayaku Launched in Japan; U.S. regulatory plan unknown. Ranbaxy Launched in India; U.S. regulatory plan unknown. Pfizer, Inc. PF-05280586 In Phase 3 clinical trials.36 Rituxan® Biogen Idec, Actavis PLC / ABP 798 Stage of development unspecified.37,38 (rituximab) Inc. Amgen, Inc. 33 Samsung Bioepis Biosimilar Pipeline; Accessed March 9, 2015; http://www.samsungbioepis.com/ 34 http://finance.yahoo.com/news/biogen-announces-ema-validation-marketing-060000889.html 35 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 36 Pfizer Pipeline, as of February 27, 2015 (http://www.pfizer.com/sites/default/files/product-pipeline/February_27_2015_Pipeline_Update_Final2.pdf) 37 February 18, 2015 “Actavis Outlines Standalone Pharmaceutical Pipeline at Investor Meeting” http://www.actavis.com/news/news/thomson- reuters/actavis-outlines-standalone-pharmaceutical-pipelin 38 Amgen Biosimilars Pipeline; Accessed March 9, 2015; http://www.amgenbiosimilars.com/our-products/our-pipeline/ 50356338.1.
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