Last update: 23 July 2024
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Last update: 23 July 2024
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product.
Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015 [1].
To date, FDA has approved 56 biosimilars within the product classes of: 1) insulin; 2) granulocyte colony-stimulating factor; 3) monoclonal antibodies and 4) tumour necrosis factor-alpha (TNF-α), 5) vascular endothelial growth factor (VEGF) inhibitor, as shown in see Table 1.
Of these, 13 are approved as interchangeable biosimilars, as shown in Table 2. Table 3 presents the follow-on biologicals approved by the FDA.
In the FDA approval of biosimilars, infliximab-dyyb was approved under two brand names: Inflectra (Pfizer) in 2016 and Zymfentra (Celltrion) in 2023. On 5 March 2024, denosumab-bddz from Sandoz was approved under two brand names: Jubbonti and Wyost.
Table 1: FDA approved biosimilars* | ||||
Product name | Active substance | Therapeutic area | Authorization date | Manufacturer/ Company name |
Abrilada (adalimumab-afzb) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
15 Nov 2019 5 Oct 2023§ |
Pfizer |
Ahzantive (aflibercept-mrbb) | aflibercept |
Age-related neovascular (wet) macular degeneration (nAMD) Diabetic macular oedema Diabetic retinopathy Macular oedema |
28 Jun 2024 | Formycon/Klinge Pharma |
Alymsys (bevacizumab-maly) | bevacizumab |
NSCLC Cervical cancer Colorectal cancer Glioblastoma Ovarian, fallopian tube or primary peritoneal cancer Renal cell carcinoma |
13 Apr 2022 | Amneal Pharmaceuticals |
Amjevita (adalimumab-atto) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
23 Sep 2016 | Amgen |
Avsola (infliximab-axxq) | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
6 Dec 2019 | Amgen |
Avzivi (bevacizumab-tnjn) | bevacizumab |
Cervical cancer Epithelial ovarian, fallopian tube, or primary peritoneal cancer Metastatic colorectal cancer Metastatic renal cell carcinoma Non-squamous non-small cell lung cancer Recurrent glioblastoma in adults |
6 Dec 2023 | Bio-Thera Solutions, marketed by Sandoz |
Bekemv (eculizumab-aeeb) | eculizumab |
Atypical haemolytic uraemic syndrome (aHUS) Paroxysmal nocturnal haemoglobinuria (PNH) |
28 May 2024§ | Amgen |
Byooviz (ranibizumab-runa) | ranibizumab |
Macular oedema Macular oedema following RVO mCNV Wet AMD |
17 Sep 2021 Jun 2022§ |
Samsung Bioepis |
Cimerli (ranibizumab-eqrn) | ranibizumab |
Diabetic macular oedema Diabetic retinopathy Macular oedema following RVO mCNV Wet AMD |
2 Aug 2022§ | Coherus Biosciences/22 Jan 2024 acquired by Sandoz |
Cyltezo (adalimumab-adbm) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
25 Aug 2017 15 Oct 2021§ |
Boehringer Ingelheim |
Erelzi (etanercept-szzs) | etanercept |
Axial spondyloarthritis Polyarticular juvenile idiopathic arthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis |
30 Aug 2016 | Sandoz |
Eticovo (etanercept-ykro) | etanercept |
Axial spondyloarthritis Polyarticular juvenile idiopathic arthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis |
25 Apr 2019 | Samsung Bioepis |
Fulphila (pegfilgrastim-jmdb) | pegfilgrastim | Febrile neutropenia | 4 Jun 2018 | Biocon/Mylan |
Fylnetra (pegfilgrastim-pbbk) | pegfilgrastim | Febrile neutropenia | 26 May 2022 | Kashiv Biosciences (Amneal Pharmaceuticals) |
Hadlima (adalimumab-bwwd) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
23 Jul 2019 | Samsung Bioepis |
Hercessi (trastuzumab-strf) | trastuzumab |
HER2 breast cancer HER2 metastatic gastric or gastroesophageal junction adenocarcinoma |
29 Apr 2024 | Henlius, marketed by Accord |
Herzuma (trastuzumab-pkrb) | trastuzumab | Breast cancer | 14 Dec 2018 | Celltrion/Teva Pharmaceutical Industries |
Hulio (adalimumab-fkjp) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
6 Jul 2020 | Mylan/Biocon |
Hyrimoz (adalimumab-adaz) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
30 Oct 2018 | Sandoz |
Idacio (adalimumab-aacf) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
13 Dec 2022 | Fresenius Kabi |
Inflectra (infliximab-dyyb) see also Zymfentra | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
5 Apr 2016 | Pfizer (Hospira) |
Ixifi (infliximab-qbtx) | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
13 Dec 2017 | Pfizer |
Jubbonti (denosumab-bddz) see also Wyost | denosumab |
Postmenopausal osteoporosis Osteoporosis in men Breast cancer treatment–induced bone loss Prostate cancer treatment–induced bone loss Glucocorticoid-induced osteoporosis |
5 Mar 2024§ | Sandoz |
Kanjinti (trastuzumab-anns) | trastuzumab |
HER2 breast cancer HER2 metastatic gastric or gastroesophageal junction adenocarcinoma |
13 Jun 2019 | Amgen |
Lusduna# (tentative approval) | insulin glargine | Diabetes | 22 Jul 2018 | Merck Sharpe & Dohme |
Mvasi (bevacizumab-awwb) | bevacizumab |
NSCLC Colorectal neoplasms Renal cell carcinoma Ovarian neoplasms Breast neoplasms |
14 Sep 2017 | Amgen/Allergan |
Nivestym (filgrastim-aafi) | filgrastim |
Autologous peripheral blood progenitor cell collection and therapy Bone marrow transplantation Cancer Myeloid leukaemia Neutropenia |
20 Jul 2018 | Pfizer (Hospira) |
Nypozi (filgrastim-txid) | filgrastim | Febrile neutropenia | 28 Jun 2024 | Tanvex |
Nyvepria (pegfilgrastim-apgf) | pegfilgrastim | Febrile neutropenia | 10 Jun 2020 | Pfizer (Hospira) |
Ogivri (trastuzumab-dkst) | trastuzumab |
HER2 breast cancer HER2 metastatic gastric or gastroesophageal junction adenocarcinoma |
1 Dec 2017 | Biocon/Mylan |
Ontruzant (trastuzumab-dttb) | trastuzumab |
HER2 breast cancer HER2 metastatic gastric or gastroesophageal junction adenocarcinoma |
18 Jan 2019 | Samsung Bioepis/Merck |
Opuviz (aflibercept-yszy) | aflibercept |
Diabetic macular edema Diabetic retinopathy Macular edema following retinal vein occlusion Neovascular (wet) age-related macular degenerationRetinal vein occlusion |
20 May 2024§ | Samsung Bioepis/Biogen |
Pyzchiva (ustekinumab-ttwe) | ustekinumab |
Crohn's disease plaque psoriasis psoriatic arthritis ulcerative colitis |
28 Jun 2024# | Samsung Bioepis |
Releuko (filgrastim-ayow) | filgrastim | Febrile neutropenia | 25 Feb 2022 | Kashiv Biosciences (Amneal Pharmaceuticals) |
PF708# (tentative approval) | teriparatide | Osteoporosis | 7 Oct 2019 | Pfenex |
Renflexis (infliximab-abda) | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
21 Apr 2017 | Samsung Bioepis/Merckk |
Retacrit (epoetin alfa-epbx) | epoetin alfa |
Anaemia (chronic kidney disease, Zidovudine, chemotherapy) Reduction of allogeneic red blood cell transfusions |
15 May 2018 | Pfizer (Hospira) |
Releuko (filgrastim-ayow) | filgrastim | Febrile neutropenia | 25 Feb 2022 | Kashiv Biosciences (Amneal Pharmaceuticals) |
Rezvoglar (insulin glargine-aglr) | insulin glargine | Diabetes | 17 Dec 2021§ | Eli Lilly |
Riabni (rituximab-arrx) |
rituximab |
Chronic lymphocytic leukemia Rheumatoid arthritis Granulomatosis with polyangiitis Non-Hodgkin lymphoma |
17 Dec 2020 | Amgen |
Ruxience (rituximab-pvvr) | rituximab |
Chronic lymphocytic leukemia Granulomatosis with polyangiitis Non-Hodgkin lymphoma |
23 Jul 2019 | Pfizer |
Selarsdi (ustekinumab-aekn) | ustekinumab |
plaque psoriasis (PsO) psoriatic arthritis (PsA) |
16 Apr 2024 | |
Semglee (insulin glargine-yfgn) | insulin glargine | Diabetes |
11 Jun 2020 28 Jul 2021§ |
Biocon/Viatris (formerly Mylan) |
Simlandi (adalimumab-ryvk) | adalimumab |
Ankylosing Spondylitis Crohn’s Disease Hidradenitis Suppurativa Juvenile Idiopathic Arthritis Plaque Psoriasis Psoriatic Arthritis Rheumatoid Arthritis Ulcerative Colitis Uveitis |
23 Feb 2024§ | Alvotech, marketed by Teva |
Stimufend (pegfilgrastim-fpgk) | pegfilgratim | Supportive care medicine for patients with non-myeloid cancer | 1 Sep 2022 | Fresenius Kabi |
Tofidence (tocilizumab-bavi) | tocilizumab |
Polyarticular Juvenile Idiopathic Arthritis Rheumatoid Arthritis Systemic Juvenile Idiopathic Arthritis |
29 Sep 2023 | Bio-Thera Solutions, marketed by Biogen |
Trazimera (trastuzumab-qyyp) | trastuzumab |
HER2 breast cancer HER2 metastatic gastric or gastroesophageal junction adenocarcinoma |
11 Mar 2019 | Pfizer |
Truxima (rituximab-abbs) | rituximab | Non-Hodgkin lymphoma | 28 Nov 2018 | Celltrion/Teva Pharmaceutical Industries |
Tyenne (tocilizumab-aazg) | tocilizumab |
Giant cell arteritis Polyarticular juvenile idiopathic arthritis Rheumatoid arthritis Systemic juvenile idiopathic arthritis |
7 Mar 2024 | Fresenius Kabi |
Tyruko (natalizumab-sztn) | natalizumab |
Multiple sclerosis Relapsing-remitting multiple sclerosis |
25 Aug 2023 | Sandoz |
Udenyca (pegfilgrastim-cbqv) | pegfilgrastim | Febrile neutropenia | 2 Nov 2018 | Coherus Biosciences |
Vegzelma (bevacizumab-adcd) | bevacizumab |
Glioblastoma Metastatic breast cancer Metastatic colorectal cancer Non-small cell lung cancer |
27 Sep 2022 | Celltrion |
Wezlana (ustekinumab-auub) | ustekinumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
31 Oct 2023§ | Amgen |
Wyost (denosumab-bddz) see also Jubbonti |
denosumab |
Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours Giant cell tumour of bone Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy |
5 Mar 2024§ | Sandoz |
Yesafili (aflibercept-jbvf) | aflibercept |
Diabetic macular edema Diabetic retinopathy Macular edema following retinal vein occlusion Neovascular (wet) age-related macular degeneration Retinal vein occlusion |
20 May 2024§ | Biocon |
Yuflyma (adalimumab-aaty) | adalimumab |
Ankylosing spondylitis Crohn disease Hidradenitis suppurativa Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
May 2023 | Celltrion |
Yusimry (adalimumab-aqvh) | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
17 Dec 2021 | Coherus Biosciences/27 June 2024 acquied by Hong Kong King-Friend Industrial |
Zarxio (filgrastim-sndz) |
filgrastim |
Autologous peripheral blood progenitor cell collection and therapy Bone marrow transplantation Cancer Myeloid leukaemia Neutropenia |
6 Mar 2015 | Sandoz |
Ziextenzo (pegfilgrastim-bmez) | pegfilgrastim | Febrile neutropenia | 4 Nov 2019 | Sandoz |
Zymfentra (infliximab-dyyb) see also Inflectra | infliximab | maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease | 23 Oct 2023 | Celltrion |
Zirabev (bevacizumab-bvzr) | bevacizumab |
Breast neoplasms Colorectal neoplasms NSCLC Ovarian neoplasms Renal cell carcinoma |
27 Jun 2019 | Pfizer |
*Data updated 23 July 2024 §Date approved as an interchangeable biosimilar. Semglee was approved as the first interchangeable biosimilar in the US on 28 July 2021 [5]. #Provisional determination on interchangeability AMD: age-related macular degeneration; FDA: US Food and Drug Administration; mCNV: myopic choroidal neovascularization; NSCLC: non-small-cell lung carcinoma; ODAC: Oncologic Drugs Advisory Committee; RVO: retinal vein occlusion. |
Table 2 details the total number of biosimilars and interchangeable biosimilars approved by the FDA since 2017. The 13 interchangeable biosimilars approved are: Abrilada (adalimumab-afzb); Byooviz (ranibizumab-runa); Cimerli (ranibizumab-eqrn); Cyltezo (adalimumab-adbm); Jubbonti (denosumab-bddz); Opuviz (aflibercept-yszy); Rezvoglar (insulin glargine-aglr); Semglee (insulin glargine-yfgn); Simlandi (adalimumab-ryvk); Wezlana (ustekinumab-auub); Wyost (denosumab-bddz), Yesafili (aflibercept-jbvf). The FDA granted provisional determination for interchangeability designation for Pyzchiva [2].
Table 2: Overview of biosimilars and Interchangeable biosimilars approved by FDA* | |||
Approved biosimilars | |||
Brand name | Active substance | Total no. approved | Interchangeable designation |
Humira | adalimumab | 10 | 4 |
Eylea | aflibercept | 2 | 2 |
Avastin | bevacizumab | 5 | |
Prolia & Xgeva | denosumab | 2 | 2 |
Soliris | eculizumab | 1 | 1 |
Epogen/Procrit | epoetin alfa | 1 | |
Enbrel | etanercept | 2 | |
Neupogen | filgrastim | 3 | |
Remicade | infliximab | 5 | |
Lantus | insulin glargine | 2 | 2 |
Tysabri | natalizumab | 1 | |
Neulasta | pegfilgrastim | 6 | |
Lucentis | ranibizumab | 2 | 2 |
Rituxan | rituximab | 3 | |
Actemra | tocilizumab | 2 | |
Herceptin | trastuzumab | 6 | |
Stelara | ustekinumab | 3 | 1 |
TOTAL | 56 | 14 | |
*Data updated 23 July 2024 |
FDA has approved six follow-on biologicals in the product classes of enoxaparin sodium (Enoxaparin sodium and M-Enoxaparin); insulin (Admelog, Basaglar and Lusduna) and teriparatide (PF708), see Table 3. The approval for one insulin glargine (Lusduna) and teriparatide follow-on biological (PF708) are tentative pending patent litigation.
Table 3: FDA approved follow-on biologicals* | ||||
Product name | Active substance | Therapeutic area | Authorization date | Manufacturer/ Company name |
Admelog# | insulin lispro | Diabetes | 11 Dec 2017 | Sanofi |
Basaglar# | insulin glargine | Diabetes | 16 Dec 2015 |
Eli Lilly/ Boehringer Ingelheim |
Enoxaparin sodium§ | Enoxaparin sodium | Prophylaxis of Deep Vein Thrombosis | 14 Mar 2019 | Amphastar Pharms |
M-Enoxaparin§ | Enoxaparin sodium | Prophylaxis of Deep Vein Thrombosis | 23 Jul 2010 | Momenta/Sandoz, India/Germany |
Lusduna# (tentative approval) | insulin glargine | Diabetes | 20 Jul 2017 | Merck Sharpe & Dohme |
PF708# (tentative approval) | teriparatide | Osteoporosis | 7 Oct 2019 | Pfenex |
*Data updated 11 March 2024 #Admelog, Basaglar, Lusduna and PF708 were approved via the FDA’s abbreviated 505(b)(2) pathway as follow-on products not as biosimilars. No insulin lispro or glargine products were licensed under the Public Health Service Act at the time of filing, so there was no ‘reference product’ for a proposed biosimilar product. §Product not approved under the 351k legislation in the US |
As of the end of July 2024, the FDA has approved a total of 58 biosimilars, including six follow-on biologicals that did not undergo the BLA 351K process for use in the US.
Two somatropins – Omnitrope (Sandoz) and Valtropin (LG Life Sciences, Biopartners) – have been approved by FDA in 2007 as a follow-on protein product. Omnitrope is being marketed in the US since 2007 for GHD in children and adults.
The landmark decision by FDA to approve its first biosimilar came in the wake of a unanimous vote two months earlier by FDA advisors who recommended approval of Zarxio [3]. Sandoz, the generics division of Novartis, already markets its biosimilar filgrastim product under the brand name Zarzio in more than 40 countries outside the US [4].
Most of the products approved so far have been approved as biosimilars, not as interchangeable products. According to the BPCI Act, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
FDA has designated placeholder non-proprietary names that include a 4-digit random suffix, for all of the biosimilars that it has approved to date. The agency issued final guidance on the naming of biologicals in January 2017 [5].
FDA made a landmark decision on 28 July 2021 to approve the insulin glargine biosimilar Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product approved in the US for the treatment of diabetes [6].
Related articles
Biosimilars approved in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
3. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-filgrastim-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application
5. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
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Source: US FDA
Dear Kauntay Parekh, thank you for your valid and interesting comment on this article. Thank you for sharing your thoughts on this subject. We would be delighted if you would consider submitting a short Commentary paper on this topic to GaBI Journal.
Please feel free to reach us at editorial@gabi-journal.net for further information.
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Best regards, Louis.
Hi, Hemanth Kumar,
1. How many phase I, II, III trials are needed to be conducted for a Biosimilar in US and EU?
Ans: In US and EU, biosimilar applicant has to discuss with drug regulatory authority to decide the clinical trial (CT) pathway for the particular product (For US FDA and for EU EMA). These regulatory authority devise the CT pathway based on the products similarity with reference biologic (Based on analytical data).
Overall, the more similar the biosimilar product to reference product based on analytical data, the lesser CT will be required.
2. What is the trial duration for these trials (In general)?
Ans: Trial duration varies from product to product but generally these trials get completed within 2-4 years.
3. How the development timelines and trial size differ for biosimilars from their reference biologic drugs?
Ans: Unlike reference product sponsor, biosimilar applicant has to prove similarity, efficacy, safety and toxicity data comparable to reference biologic. Hence, the CT size required for biosimilar is smaller than the reference biologic.
Dear Sir/Madam,
Thank you very much for your articles and news about Biosimilars and generics world at gabionline.
I observed from one of your articles that it takes less than 2 years for completion of Biosimilar pivotal trials, I have a few queries regarding that.
1. How many phase I, II, III trials are needed to be conducted for a Biosimilar in US and EU?
2. What is the trial duration for these trials (In general) ?
3. How the development timelines and trial size differ for Biosimilars from their reference biologic drugs?
I would be grateful if you can answer these queries
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