NEWS And EVENTS
The Patent Cliff Threatens Billions of Global Pharmaceutical Sales
The patent cliff is real. During 2010 -2017 and during 2019-2024 approximately USD $150B and $198B respectively either have been and or are at risk of losing patent protection. Worldwide prescription drug sales are expected to grow at a CAGR of 6.9 percent to $842 billion during the 2019-2024 time period. This is triple the CAGR seen for 2010-2019 and is driven by an increase in FDA approvals for novel drugs and growth in the oncology therapies and orphan drugs markets.
Healthcare Economics (HCE) has developed extensive contacts with manufacturers, technology clusters, and academia to supply the needed link into each sector with its proven experience and globally developed extensive network. Therefore, the opportunity is immense for HCE to partner with firms to supplement their pipelines to ensure future success.
USA Biosimilar Approval (A) and Launch Dates (L)
| Originator | Trade Name & Class | Molecule Type | Innovator & Drug Name Approval & Launch Dates | Innovator & Drug Name Approval & Launch Dates | Innovator & Drug Name Approval & Launch Dates | Innovator & Drug Name Approval & Launch Dates | Innovator & Drug Name Approval & Launch Dates | Innovator & Drug Name Approval & Launch Dates |
|---|---|---|---|---|---|---|---|---|
| Genentech | Herceptin Oncology | Trastuzumab | Mylan Ogivri Dec 2017(A) Nov 2019(L) | Teva Herzuma Dec 2018(A) Mar 2019(L) | Merck Ontruzant Jan 2019(A) Apr 2020(L) | Pfizer Trazimera Mar 2019(A) Feb 2020(L) | Amgen Kanjinti Jun 2019(A) Jul 2019(L) | Accord Hercessi Apr 2024(A) |
| Genentech | Rituxan Oncology | Rituximab | Teva Truxima Nov 2018(A) Nov 2019(L) | Pfizer Ruxience Jul 2019(A) Jan 2020(L) | Amgen Riabni Dec 2020(A) Jan 2021(L) | |||
| Genentech | Avastin Oncology | Bevacizumab | Amgen Mvasi Sept 2017(A) Jul 2019(L) | Pfizer Zirabev Jun 2019(A) Jan 2020(L) | Amneal Alymsys Apr 2022(A) Oct 2022(L) | Cellitron Vegzelma Sept 2022(A) Apr 2023(L) | Sandoz Avzivi Dec 2023(A) Dec 2023(L) | |
| Genentech | Ranibizumab Ophthalmology | Lucentis | Biogen Byooviz Sept 2021(A) Jul 2022(L) | Coherus Cimerli Aug 2022(A) Oct 2022(L) | ||||
| Genentech | Actemra IV/SC Immunomodulator | Tocilizumab | Fresenius Tyenne Mar 2024(A) Apr 2024(L) | Biogen Tofidence Sept 2023(A) May 2024(L) | ||||
| J&J | Remicade Immunomodulator | Infliximab | Pfizer Inflectra Apr 2016(A) Nov 2016(L) | Pfizer Ixifi Dec 2017(A) Not launched in US | Organon Renflexis Apr 2017(A) Jul 2018(L) | Amgen Avsola Dec 2019(A) Jul 2020(L) | ||
| J&J | Stelara Immunomodulator | Ustekinumab | Biocon Yesintek Dec 2024 (A) Feb 2025 (L) | Celltrion Steqeyma Dec 2024 (A) Feb 20245(L) | ||||
| J&J | Stelara Immunomodulator | Ustekinumab | Amgen Wezlana Oct 2023(A) Jan 2025(L) | Teva Selarsdi Oct 2023(A) Apr 2024(L) | Sandoz Pyzchiva June 2024(A) Feb 2025(L) | Fresenius Otulfi Sept 2024(A) Feb 2025(L) | Accord Imuldosa Oct 2024(A) May 2025(L) | |
| AbbVie | Humira Immunomodulator | Adalimumab | Meitheal Yusimry Sept 2016 (A) Jul 2023 (L) | Fresenius Idacio Dec 2022(A) Jul 2023(L) | Celltrion Yuflyma May 2023 Jul 2023(L) | Teva Simlandi Feb 2024 May 2024(L) | ||
| AvbbVie | Humira Immunomodulator | Adalimumab | Amgen Amjevita Sept 2016 (A) Jul 2023 (L) | Biocon Hulio Jul 2020 (A) Jul 2023 (L) | B I Cyltezo Oct 2021 (A) Jul 2023 (L) | Organon Hadlima Aug 2022 (A) Jan 2023 (L) | Sandoz Hyrimoz Mar 2023 (A) Jul 2023 (L) | Pfizer Abrilada Oct 2023 (A) Nov 2023 (L) |
| Amgen | Enbrel Immunomodulator | Etanercept On-going Litigation Forecasted Launch Date 2028-2029 | Sandoz Erelzi Aug 2016(A) | Samsung Eticovo Apr 2019(A) | ||||
| Amgen & J & J | Epogen Procrit Supportive Care | Epoetin Alfa | Pfizer/Vifor Retacrit May 2018(A) Nov 2018(L) | |||||
| Amgen | Neupogen Supportive Care | Filgrastim | Sandoz Zarxio Mar 2015(A) Sept 2015(L) | Pfizer Nivestym Jul 2018(A) Oct 2018(L) | Amneal Releuko Feb 2022(A) Nov 2022(L) | Tanvex Nypozi Jun 2024(A) Jun 2024(L) | ||
| Amgen | Neulasta Supportive Care | Pegfilgrastim | Mylan Fulphila Jun 2018(A) Jul 2018(L) | Intas Yusimry Nov 2018(A) Jan 2019(L) | Sandoz Ziextenzo Nov 2019(A) Nov 2019(L) | Pfizer Nyvepria June 2020(A) Dec 2020(L) | ||
| Amgen | Neulasta Supportive Care | Pegfilgrastim | Amneal Fylentra May 2022 (A) May 2023 (L) | Fresenius Stimufend Sept 2022 (A) Feb 2023 (L) | ||||
| Amgen | Xgeva Bone Health Support | Denosumab | Sandoz Jubbonti Mar 2024(A) Not Yet Launched | |||||
| Amgen | Xgeva Bone Health Support | Denosumab | Sandoz Wyost Mar 2024(A) Not Yet Launched | |||||
| Lilly | Humalog Insulin | Insulin Lispro | Sanofi Admelog Dec 2017(A) Apr 2018(L) | |||||
| Sanofi | Lantus Insulin | Insulin Glargine | Lilly Basaglar Dec 2015(A) Dec 2016(L) | |||||
| Regeneron | Eylea Ophthalmology | Aflibercept | Amgen Pavblu Aug 2024(A) Oct 2024(L) | Biocon Yesafili May 2024(A) Jul 2025(L) | Biogen Opuviz May 2024(A) Not Yet Launched | Formycon Ahzantive Jun 2024(A) Not Yet Launched | Sandoz Enzeevu Aug 2024(A) Not Yet Launched | |
| Biogen | Tysabri Immunomodulator | Natalizumab | Sandoz Tyruko Aug 2023(A) Not Yet Launched | |||||
| Alexion | Soliris Immunomodulator | Eculizumab | Amgen Bkemv May 2024(A) Not Yet Launched | Samsung Epysqli July 2024(A) Not Yet Launched |