Biosimilars – Corporate Strategies – Appendix

Amgen, Q3 2019 Amgen Earnings Conference Call Presentation. Accessed on October 31, 2019.

Baselga J, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. NEJM. Jan 12;366(2):109-19.

Bassi S, et al. Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem-cell transplantation for haematological malignancies: a 4-year, single-institute experience with different conditioning regimens. Blood Transfusion. 2015;13:478-483.

Crosson FJ, et al. Report to the Congress: Medicare and the Health Care Delivery System. Medpac. June 15, 2017.

Chaffee J. 10 Drugs with Big Price Increases—and Ways Blue Cross is Helping Members. MI Blues Perspectives. January, 2018.

Cohen MH et al. Approval Summary: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil for the First-Line Treatment of Patients With Recurrent Locoregional or Metastatic Squamous Cell Head and Neck Cancer. The Oncologist. 2013;18(4):460-466.

Davies A, et al. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomized Phase 3 study. Lancet Oncology. 2014;15(3):343-352.

DRG (2018, February 27). Market Analyzer. Retrieved from

Egeth M, et al. Patient and Healthcare Professionals Preference for Brenzys vs. Enbrel Autoinjector for Rheumatoid Arthritis: A Randomized Crossover Simulated-Use Study, Advances in Therapy. April, 2017.

EMA. Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Erythropoietins (Revision), March, 2010.

EMA. Guideline on Nonclinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Human Insulin and Insulin Analogues, April, 2014.

EMA. Guidelines on Similar Biological Medicinal Products, October, 2014.

Gligorov J, et al. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. May 23, 2017.

Goede V, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. NEJM. 2014 Mar 20;370(12):1101-10.

Goede V, et al. Obinutuzumab as frontline treatment of chronic lymphocytic leukemia: updated results of the CLL11 study. Leukemia. 2015 Jul;29(7):1602-4.

FDA. Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act, August, 2014.

FDA, Orphan Drug Designations and Approvals: Accessed on October 28, 2019.

Gupta S. Opportunities and Challenges in Biosimilar Development. BioProcess, Internationa. May 18, 2017..

Haag-Weber M, et al. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α [HX575] in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clinical Nephrology. 2012;77:8-17.

Healio. Largest dialysis providers in the United States, 2019: Accessed October 27, 2019.

Hurvitz SA, et al. Pathologic complete response (pCR) rates after neoadjuvant trastuzumab emtansine (T-DM1 [K]) + pertuzumab (P) vs docetaxel + carboplatin + trastuzumab + P (TCHP) treatment in patients with HER2-positive (HER2+) early breast cancer (EBC) (KRISTINE). Journal of Clinical Oncology. May 2016.

ICER. Unsupported Price Increase Report, 2019: Accessed on October 31, 2019.

Kishioka Y. Regulatory Framework for Biotherapeutic Products Including Similar Biotherapeutic Products. PMDA. March 2015.

Krivoshiev S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Advances in Therapy. 2010;27:105-117.

Marcus R, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. NEJM. 2017 Oct 5;377(14):1331-1344.

Nephrology News & Issues. (2017). The largest dialysis providers in 2017: More jump on integrated care bandwagon. [Press release]. Retrieved from

Perez E, et al. Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study. Journal of Clinical Oncology. January 10, 2017.

Ostrom CM. What’s behind the whopping price tags on the newest generation of drugs: The story behind the production of Enbrel, Amgen’s popular rheumatoid arthritis drug, provides insights as to why bioengineered drugs are so expensive. Seattle Times. August 18, 2008

Pivot X, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70.

PlantForm. news update, September 2017.

Rule S, et al. Subcutaneous vs. intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. Journal of Medical Economics. 2014;17[7]:459-468.

Samsung Bioepis. press release, November 6, 2019. Samsung Bioepis enters into commercialization agreement for next-generation biosimilar candidates.

Sandoz. press release, January 18, 2018.

Sehn LH, et al. GADOLIN: primary results from a Phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. 20th EHA Congress, 11-14 June 2015; Abstract LB691.

Seidl A, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharmaceutical Research. 2011;29:1454-1467.

Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013 May;14(6):461-71. Rheumatology and Therapy. 2016 Jun;3(1):77-89

Thakur K, et al. Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali®) Versus Etanercept (Enbrel®) – Findings from a Nurse Survey in Europe.

The Welfare fund of plumbers local union no. 200 v. Johnson & Johnson et al (2:17-cv-05481), Pennsylvania Eastern District Court, Filed 12/07/2017. Complaint for violations of the Sherman antitrust act and state antitrust and consumer protection statutes. PacerMonitor Mobile Federal and Bankruptcy Court PACER Dockets. Web. 27 Feb. 2018.

Verma S, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. The New England Journal of Medicine. 2012;367(19):1783-1791.

Vitolo U, et al. Obinutuzumab or Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma. Journal of Clinical Oncology. August 10, 2017.

Walker N. Single-use Technology Integral to Advancing Biomanufacturing. Contract Pharma. March 9, 2016

Zharkov et al. Development pathways for subcutaneous formulations of biologics versus biosimilar development . Expert Review of Precision Medicine and Drug Development, March 1, 2019.