Biosimilars Breakout Session Sean McGowan, Sr. Director, Biosimilars, AmerisourceBergen Michelle Jesse, Director, Biosimilars, AmerisourceBergen U.S. biosimilar market By the numbers
28 Biosimilar approvals by the FDA 18 Biosimilar products launched in the US 9 Biosimilar products launched since August 2019 7 Oncology biosimilar products launched since August 2019 5 Years since the launch of the 1st biosimilar in the U.S. (ZARXIO®) U.S. biosimilar market landscape As of October 1, 2020
CLASS SUPPORTIVE CARE ONCOLOGY TNF BLOCKERS
MOLECULE Filgrastim Epoetin Pegfilgrastim Rituximab Bevacizumab Trastuzumab Infliximab Etanercept Adalimumab
NEUPOGEN EPOGEN NEULASTA RITUXAN AVASTIN HERCEPTIN REMICADE ENBREL HUMIRA INNOVATOR (Amgen) (Amgen) (Amgen) (Genentech) (Genentech) (Genentech) (JnJ) (Amgen) (AbbVie)
ZARXIO RETACRIT FULPHILA TRUXIMA MVASI KANJINTI INFLECTRA LAUNCHED Sandoz Pfizer/Vifor Mylan Teva Amgen Amgen Pfizer Biosimilars referencing Sep 2015 Nov 2018 Jul 2018 Nov 2019 Jul 2019 Jul 2019 Nov 2016 Ongoing Manufacturer Humira Litigation Launch Date NIVESTYM UDENYCA RUXIENCE ZIRABEV OGIVRI RENFLEXIS will launch Pfizer Coherus Pfizer Pfizer Mylan Merck in 2023 Oct 2018 Jan 2019 Jan 2020 Jan 2020 Nov 2019 Jul 2018
ZIEXTENZO TRAZIMERA AVSOLA ERELZI AMJEVITA Sandoz Pfizer Amgen Sandoz Amgen Nov 2019 Feb 2020 July 2020 Aug 2016 Sep 2016
NYVEPRIA HERZUMA IXIFI ETICOVO CYLTEZO APPROVED Pfizer Teva Pfizer Samsung BI March 2020 Manufacturer June 2020 Dec 2014 Apr 2019 Aug 2017 *Not launching in the U.S. FDA Approval HYRIMOZ Date ONTRUZANT Merck Sandoz Apr 2020 Oct 2018 HADLIMA Merck Jul 2019 ABRILADA Pfizer Nov 2019
HULIO Mylan Jul 2020 U.S. biosimilar market pipeline As of October 1, 2020
CLASS SUPPORTIVE CARE ONCOLOGY TNF BLOCKERS
MOLECULE Filgrastim Epoetin Pegfilgrastim Rituximab Bevacizumab Trastuzumab Infliximab Etanercept Adalimumab Ustekinumab
NEUPOGEN EPOGEN NEULASTA RITUXAN AVASTIN HERCEPTIN REMICADE ENBREL HUMIRA STELARA IV/SC INNOVATOR (Amgen) (Amgen) (Amgen) (Genentech) (Genentech) (Genentech) (JnJ) (Amgen) (AbbVie) (JnJ)
PIPELINE GRASTOFIL APO-EPO TPI-120 ABP 798 SB8 TRASTUZUMA NI-071 CHS-0214 CHS-1420 NEULARA Accord Apotex Amneal-Adello Amgen Merck/Samsung B Apotex Sagent Coherus Coherus NeuClone Manufacturer Pending Ph III Ph I Pending Pending Pre-Clin Ph III Ph III Ph III Ph I Clinical Phase FILGRASTIM LAPELGA DRL RI CT-P16 TX05 REMSIMA SC YLB113 M923 CT-P43 Celltrion KASHIV Accord Dr. Reddy’s Celltrion Tanvex Lupin Momenta Celltrion Pending Ph III Ph III Amneal-Adello Ph III Phase I Ph III Withdrawn Ph I Pending PEG- BEVACIZUMA GP2018 GRAFEEL SAIT101 EG12014 MSB11022 FYB202 B Apotex Sandoz Dr Reddy’s AZ-Archigen Sandoz Fresenius Formycon LUPIFIL Ph I Ph I Ph I Ph III Ph III Ph III Ph I Lupin Ph I LUPIFIL-P RITUXIMAB FKB238 HD201 AVT02 DMB-3115 Lupin Apotex AZ-Centus Prestige Bio Alvotech Dong-A Pharma TX01 Ph I Ph I Ph III Ph III Ph I Ph I Tanvex CRL MSB11455 TX16 AP063 MYL-1401A BAT2206 Dr Reddy’s Tanvex Nichi-Iko Mylan Bio-Thera Pending Ph 1 Ph I Ph III Ph I
BEVZ92 ONS-3010 Amneal Oncobiologics Ph1 Ph III
BMAB-100 Biocon/Mylan Pending U.S. biosimilar market pipeline As of October 1, 2020
CLASS OPHTHALMOLOGY IMMUNOSUPPRESSANT BONE HEALTH
MOLECULE Ranibizumab Aflibercept Eculizumab Omalizumab Natalizumab Denosumab
LUCENTIS EYLEA SOLIRIS XOLAIR TYSABRI PROLIA INNOVATOR (Genentech) (Regeneron) (Alexion) (Alexion) (Genentech) (Amgen)
SB11 M710 SB12 CT-P39 TYSABRI BIOSIM PIPELINE GP2411 Samsung/Biogen Momenta Samsung Celltrion Biogen Sandoz/Hexal Manufacturer Ph III Ph III Ph I Ph I Ph III Ph III Clinical Phase XLUCANE ABP 938 ABP 959 GBR 310 PB006 Xbrane Amgen Amgen Glenmark Polpharma Ph III Ph III Ph III Phase I Ph III LY06006 Luye Pre-Clin LUCENTIS BIOSIM FYB203 Lupin Formycon Ph I Pre-Clin CT-P41 FYB201 SB15 Celltrion Coherus (Formycon) Samsung/Bioepis Pre-Clin Ph III Ph III
CHS-3351 ALT-L9 Coherus Alteogen Pre-Clin Pre-Clin
SCD411 Sam Chun Dang Ph III U.S. biosimilar market pipeline As of October 1, 2020
INSULIN CLASS (Analog and Fast Acting) GROWTH HORMONE INFERTILITY
Corifollitropin Follitropin Follitropin Insulin Lispro Insulin Aspart Insulin Glargine MOLECULE Somatropin Somapacitan Alfa Alfa Delta
HUMALOG NOVOLOG LANTUS GENOTROPIN NORDITROPIN N/A GONAL-F N/A INNOVATOR (Eli Lilly) (NovoNordisk) (Sanofi) (Alexion) (NovoNordisk) New formulation (EMD Serono) Similar to Gonal-F
PIPELINE HDV Insulin MYL-1601D – BASALIN MOD-4023 NN8640 – Elonva – Afolia – Rekovelle - Lispro - SubQ Inj SubQ Somatrogon Inj SubQ SubQ SubQ SubQ Manufacturer Diasome Mylan/Biocon Gan&Lee/Sandoz OPKO/Pfizer Novo Merck Fertility/Gedeon Ferring Clinical Phase Ph II Ph III Ph III Ph III Ph III CRL Ph III Phase III
TransCon Insulin Lispro SAR341402 – Insulin Glargine 300 hGH - SubQ Biocon - SubQ SubQ Biocon - SubQ Ascendis Biocon/Mylan Sanofi Mylan/Biocon Pending Pre-Clin Phase III Pre-Clin The future of the category Herfindahl-Hirshman Index of Market Concentration and Shares by Competitor, Q2 2020
Insulin lispro Infliximab Insulin glargine Bevacizumab Filgrastim 0.83 0.71 0.59 0.53 0.32
Higher Market Lower Market Concentration Concentration
(Fewer and/or (Many and/or disparate sized smaller sized competitors) competititors)
1.0 0.0
Illustrative Illustrative
Rituximab Epoetin alfa Pegfilgrastim Trastuzumab 0.73 0.64 0.58 0.52
Originator Biosimilar 1 Biosimilar 2 Biosimilar 3 Biosimilar 4 Biosimilar 5
Source: IQVIA National Sales Perspectives, Jun 2020 Challenges and opportunities for biosimilars
Payer and reimbursement
Inventory management
Interchangeability
COVID-19
The unknown Challenges and opportunities for biosimilars
Payer and reimbursement Payer and reimbursement 2019 Biologics Market Segmented by Status of Biosimilar Competition, Biosimilar Development and Market Exclusivity
Originator protected 91% $61 Billion Molecules facing 19% biosimilar competition Molecules with $40 Billion biosimilars in 50% development Originator unprotected 9% $67 Billion $6 Billion Molecules with Biologics market 64% potential future $211 Billion biosimilars $135 Billion Molecules without Originator protected 88% 50% biosimilars in $60 Billion Non-recombinant/ development 17% vaccines $68 Billion $36 Billion Originator unprotected 12% $8 Billion
Source: IQVIA National Sales Perspectives, Jun 2020 Challenges and opportunities for biosimilars
Inventory management Challenges and opportunities for biosimilars
Interchangeability Challenges and opportunities for biosimilars
COVID-19 Challenges and opportunities for biosimilars
The unknown Panel discussion
Kashyap Patel, M.D. Christine Simmon Bhavesh Shah, RPh, BCOP Chief Executive Officer Executive Director, Biosimilars Council Senior Director, Hematology/Oncology Carolina Blood and Cancer Care and Senior Vice President, and Specialty Pharmacy Policy & Strategic Alliances, Boston Medical Center Association for Accessible Medicines Q&A