Biosimilars Pipeline Report
Presented by: Sean McGowan 09/30/2020Senior Director, Biosimilars AmerisourceBergen Michelle Jesse Director, Biosimilars AmerisourceBergen About This Report
Biosimilars are a promising product category, one that can provide patients and doctors with more affordable treatment options.
To date, there have been 28 approvals and 18 launches in the U.S. biosimilar market. As this market matures, its pipeline continues to grow. This reference guide is a useful tool to visualize and understand the current product landscape and potential future of this emerging market.
The market landscape chart is grouped by therapeutic class with FDA approved biosimilars (highlighted in light green) and biosimilars launched to date (highlighted in dark green) organized in columns under the relevant molecule and innovator product.
The market pipeline charts show products that have not received FDA approval and are expected to launch in one to four years. These charts suggest a bright future for biosimilars, as they document a large number of existing and new suppliers investing in biosimilars. The pipeline charts also capture the expansion of biosimilars into new therapeutic areas including ophthalmology, insulin, growth hormone, fertility and immunosuppressants. 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 Apr 2019 Aug 2017 Manufacturer June 2020 Dec 2014 *Not launching in the U.S. FDA Approval Date ONTRUZANT HYRIMOZ Merck Sandoz Apr 2020 Oct 2018 HADLIMA Merck Jul 2019 ABRILADA Pfizer Nov 2019
HULIO Mylan Jul 2020 U.S. biosimilar pipeline landscape 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 TRASTUZUMAB NI-071 CHS-0214 CHS-1420 NEULARA Accord Apotex Amneal-Adello Amgen Merck/Samsung 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 KASHIV Accord Dr. Reddy’s Celltrion Tanvex Celltrion Lupin Momenta Celltrion Pending Ph III Ph III Amneal-Adello Ph III Phase I Ph III Withdrawn Ph I Pending PEG-GRAFEEL SAIT101 BEVACIZUMAB EG12014 GP2018 MSB11022 FYB202 Dr Reddy’s AZ-Archigen Apotex Sandoz Sandoz Fresenius Formycon LUPIFIL Ph I Ph III Ph I Ph III Ph I 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
CONTINUED ON NEXT PAGE U.S. biosimilar pipeline landscape 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)
TYSABRI BIOSIM PIPELINE SB11 M710 SB12 CT-P39 GP2411 Samsung Celltrion Biogen Samsung/Biogen Momenta Sandoz/Hexal Ph I Ph I Ph III Manufacturer Ph III 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 Pre-Clin Coherus (Formycon) Samsung/Bioepis Ph III Ph III
CHS-3351 ALT-L9 Coherus Alteogen Pre-Clin Pre-Clin
SCD411 Sam Chun Dang Ph III
CONTINUED ON NEXT PAGE U.S. biosimilar pipeline landscape As of October 1, 2020
CLASS INSULIN GROWTH HORMONE INFERTILITY (Analog and Fast Acting)
Corifollitropin Follitropin Insulin Lispro Insulin Aspart Insulin Glargine Somatropin Somapacitan Follitropin MOLECULE Alfa Alfa Delta
HUMALOG NOVOLOG LANTUS NORDITROPIN GONAL-F N/A INNOVATOR GENOTROPIN N/A (Eli Lilly) (NovoNordisk) (Sanofi) (Alexion) (NovoNordisk) New formulation (EMD Serono) Similar to Gonal-F
BASALIN Afolia – Rekovelle - PIPELINE HDV Insulin MYL-1601D – MOD-4023 NN8640 – Elonva – Lispro - SubQ Inj SubQ Somatrogon Inj SubQ SubQ SubQ SubQ Manufacturer Diasome Mylan/Biocon Gan&Lee/Sandoz OPKO/Pfizer Novo Merck Fertility/Gedeon Ferring Ph III Phase III Clinical Phase Ph II Ph III Ph III Ph III Ph III CRL
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 Connect with us Find out how AmerisourceBergen is creating sustainability and longevity for biosimilars
Contact Sean and Michelle by sending an email to [email protected]
Sean McGowan Michelle Jesse Senior Director, Biosimilars Director, Biosimilars AmerisourceBergen AmerisourceBergen