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Last update: 5 February 2021
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
The originator product, Roche’s Avastin (bevacizumab), was approved by the US Food and Drug Administration (FDA) in February 2004 and by the European Medicines Agency (EMA) in January 2005 [1]. Avastin had 2016 sales of CHF 6.8 billion (Euros 5.95 billion) before the advent of biosimilars, see Table 1.
The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [1]. There are estimated to be around 15 biosimilars of bevacizumab in development [2]. Some of the bevacizumab biosimilars approved or in development are presented in Table 1.
| Table 1: Biosimilars and non-originator biologicals* of bevacizumab in development | ||
| Company name, Country | Product name | Stage of development |
| Amgen/Allergan, USA | Mvasi (ABP 215) | Approved by FDA in September 2017 [3] and by EC in January 2018 [4]. |
| Apotex (Apobiologix), Canada | - | Biosimilar in pipeline – under clinical development |
| AstraZeneca/Fujifilm Kyowa Kirin Biologics, USA/Japan | Equidacent (FKB238) | 50:50 joint venture established August 2015. Phase I trial started in November 2014. EMA recommends approval on 23 July 2020 [4]. |
| Aurobindo Pharma, India* | - | Acquired four biosimilars from TL Biopharmaceutical AG in February 2017. Approved in June 2020 the transfer of Aurobindo biosimilars business (including related R & D and manufacturing sites) to its subsidiary, CuraTeQ Biologics, a Swiss company based in Lucerne. |
| Biocad, Russia* | Avegra (BCD-021) | Phase III trial in lung cancer completed in November 2014. Phase III trial in wet AMD withdrawn. Non-originator biological approved in Russia in November 2015. |
| BIOCND, South Korea | BCD500 | Phase III trial ongoing |
| Biocon, India* | Krabeva | ‘Similar biologic’ launched in India in November 2017 [5]. Phase I PK study in Europe completed. Phase III trial in NSCLC ongoing. |
| Bio‑Thera Solutions, China* | BAT1706 | Copy biological in global phase III clinical trial. Positive results reported in February 2020. |
| BioXpress Therapeutics, Switzerland | - | In pipeline |
| Cadila Pharmaceuticals, India* | Bevaro | ‘Similar biologic’ launched in India in July 2020 [6] |
| Boehringer Ingelheim, Germany | BI 695502 | Positive results from phase I trial reported in November 2016. Announced in November 2018 that it will only pursue biosimilars in the US. |
| Celltrion, South Korea | CT-P16 | In pipeline |
| Coherus, USA | CHS-5217 | Preclinical |
| Dr Reddy’s Laboratories, India* | DRZ_BZ | Phase III |
| Laboratorio Elea, Argentina* | Lumiere | Medicamento biológico similar approved in Argentina in August 2018 [7]. |
| Hetero (Lupin), India* | Cizumab | ‘Similar biologic’ launched in India in July 2016 [5]. |
| Innovent Biologics, China* | Byvasda (IBI-305) | Positive results from phase Ib trial for bevacizumab copy biological IBI305 + TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma reported in June 2020 [8]. Positive phase III results from copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab reported in January 2021. Approved by China’s NMPA in June 2020 [9] with two new indications for the treatment treatment of paediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis extended in February 2021. |
| Mabworks, China* | MIL60 | Phase III |
| mAbxience, Spain (Argentina*) | Bevax (BEVZ92) | Medicamento biológico similar approved in Argentina [10]. Phase I trial in metastatic colorectal cancer completed in June 2017 |
| Mylan, USA | MYL 1402O | Application for approval submitted to FDA on 27 February 2020 |
| Oncobiologics/Viropro, USA | ONS-1045 | Biosimilar collaboration agreement signed in February 2013 for six biosimilars. ONS-1045, met its primary and secondary endpoints in a phase I clinical trial in October 2015. Phase III trial expected to start in 2018. |
| Pfizer, USA | Zirabev (PF-06439535) | Approved by EC in February 2019 [4]. Approved by Japan's MHLW in June 2019 [11]. Approved by Australia's TGA in November 2019 [12]. |
| PlantForm, Canada | - | Preclinical |
| Prestige Biopharma, Singapore | HD204 | Phase III trial in NSCLC expected to be completed in February 2021. |
| Qilu Pharmaceutical, China* | Ankeda (QL1101) | Approved by China's NMPA in December 2019. Positive results from phase I trial reported in March 2020 [13]. |
| Reliance Life Sciences/Lupin, India* | Bevacirel | ‘Similar biologic’ launched in India in July 2016 [5]. |
| Samsung Bioepis (Biogen/Samsung)/Merck, South Korea/USA | Aybintio (SB8); Onbevzi | Phase III trial in lung cancer ongoing (April 2016). Collaborating with 3SBio for copy biologicals in China. EC approval of Aybintio in August 2020. EMA recommends approval of Onbevzi on 13 November 2020 [4]. Positive results from phase III trial in metastatic or recurrent NSCLC reported in September 2020 [13]. China's NMPA accepts IND application developed by 3SBio and Samsung Bioepis in October 2020 [14]. |
| Shanghai Henlius Biotech (Fosun Pharma), China* | HLX04 |
Phase I trial in NSCLC started in May 2016. Essex Bio-Investment and Zhuhai Essex Bio-Pharmaceuticals to work with Henlius to co-develop a bevacizumab biosimilar for the treatment of ophthalmic diseases from October 2020 [15]. |
| Tanvex BioPharma, Taiwan | TX16 | Results of phase I PK trial in colorectal cancer in the US reported December 2017. |
| TOT Biopharm, China* | - | Phase III |
|
AMD: Age-related macular degeneration; AS: ankylosing spondylitis; CNDA: China National Drug Administration (formerly CFDA); EMA: European Medicines Agency; EC: European Commission; FDA: US Food and Drug Administration; NSCLC: non-small cell lung cancer; PK: pharmacokinetics. *See editors comment |
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Amgen is ready with its biosimilar well in advance of the patent expiry on Avastin, putting the biotech giant in a good position to be first on the market. In fact, the company has already received marketing approval for its bevacizumab biosimilar, Mvasi (ABP 215), from both FDA [3] and the EC [4]. Pfizer also received approval from the EC in February 2019 for its bevacizumab biosimilar, Zirabev (PF 06439535).
Editor's comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘medicamentos biológicos similares’ approved in Argentina, ‘copy biologicals’ approved in China, ‘similar biologics’ approved in India and ‘non-originator biologicals’ approved in Russia might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars on the horizon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-on-the-horizon
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4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
6. GaBI Online - Generics and Biosimilars Initiative. Cadila Pharmaceuticals launches two similar biologics in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/Cadila-Pharmaceuticals-launches-two-similar-biologics-in-India
7. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab and bevacizumab products approved in Australia and Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-and-Bevacizumab-products-approved-in-Australia-and-Argentina
8. GaBI Online - Generics and Biosimilars Initiative. Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-Ib-results-for-TYVYT-bevacizumab-copy-biological-IBI305
9. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda
10. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
11. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
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13. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Qilu’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Qilu-s-bevacizumab-copy-biological
14. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars
15 GaBI Online - Generics and Biosimilars Initiative. Essex and Henlius collaborate to deliver bevacizumab biosimilar for ophthalmic diseases [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Pharma-News/Essex-and-Henlius-collaborate-to-deliver-bevacizumab-biosimilar-for-ophthalmic-diseases
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Source: ClinicalTrials.gov, EMA, EU Clinical Trials Register
Approval letter of Lumiere in AMD
approval letter of Lumire in AMD.
Thank you for your valuable comments and insight received on 5 August 2018, we have followed-up on your suggestion and researched the issue further. We have added this news on the website and will make the necessary addition in the next update of the article ‘Biosimilars of bevacizumab’.
We very much appreciate your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online. Best Regards, Louis
First posted 5/8/2018 ---- Lumiere - a bevacizumab biosimilar - approved for intravitreal use for age macular degeneration in Argentina.
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