Mylan gains nod for Ogivri and launches Hulio in Europe Posted 26/10/2018

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 October 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Ogivri.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Ogivri is produced by India-based biologicals specialist Biocon and US-based partner Mylan. The companies originally had their candidate trastuzumab biosimilar (MYL‑1401O) accepted for review by EMA in August 2016 [1]. But they withdrew their application from EMA as part of ‘procedural requirements’ after implementation of corrective and preventive actions and re-inspection of Biocon’s ‘Drug Product Facility’ in Bangalore were required before a good manufacturing practice (GMP) compliance certificate would be issued for the site [2]. The pair then resubmitted their application to EMA in December 2017 [3].

The CHMP has recommended that Ogivri be approved for the treatment of breast and gastric cancer. Mylan said that this includes HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC).

The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in analytical testing, preclinical and clinical studies. Results demonstrated no clinically meaningful differences in quality, potency and safety; therefore, establishing biosimilarity to the reference product, Herceptin. In addition, the phase III clinical study (HERiTAge) demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity when compared to Herceptin in metastatic breast cancer patients [4], further reinforcing the highly similar nature of Ogivri.

Four trastuzumab biosimilars have already been approved for use in the European Union. Ontruzant (SB3) produced by Samsung Bioepis, Celltrion’s Herzuma (CT‑P6), Amgen’s Kanjinti (ABP 980) and Pfizer’s Trazimera (PF‑05280014) received European Commission (EC) approval in November 2017, and in February, May and July 2018, respectively [5].

Biocon/Mylan also received approval for Ogivri (MYL‑1401O) from the US Food and Drug Administration (FDA) and from Brazil’s ANVISA in December 2017 [6, 7].

The positive opinion by the CHMP will now be considered by the EC. The decision on approval is expected by the end of 2018.

Mylan also announced on 19 October 2018 that it had initiated the commercial launch of its adalimumab biosimilar Hulio across major markets in Europe. The EC approved Hulio in September 2018, following the adoption of a positive opinion by the CHMP, which concluded that the development programme including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with Humira [8].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. FDA advisory committee to review bevacizumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisory-committee-to-review-bevacizumab-and-trastuzumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-applications-for-pegfilgrastim-and-trastuzumab-biosimilars-from-Biocon-Mylan
4. GaBI Online - Generics and Biosimilars Initiative. Safety and immunogenicity of originator and biosimilar trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/Research/Safety-and-immunogenicity-of-originator-and-biosimilar-trastuzumab
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ogivri [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ogivri
7. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilars receive EMA and ANVISA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilars-receive-EMA-and-ANVISA-approval
8. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-and-pegfilgrastim-biosimilars-Hulio-and-Udenyca

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Source: Biocon, EMA, Mylan

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