- Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira®* and Remicade®**
- Comprehensive data packages demonstrate each biosimilar matches its respective reference medicine in terms of quality, efficacy and safety
- These regulatory submissions follow soon after two positive CHMP opinions*** for Sandoz biosimilars etanercept and rituximab further reinforcing Sandoz immunology pipeline and the broader Novartis immunology portfolio
HOLZEKIRCHEN, GERMANY I May 31, 2017 I Sandoz, a Novartis division, and the pioneer and global leader in biosimilar medicines announced today that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab) both of which are used to treat immunological diseases. Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.
“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited” said Mark Levick MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline”.
The comprehensive data packages included in the EMA submissions demonstrate biosimilarity of the proposed biosimilars to their respective reference medicines, with analytical, preclinical and clinical data matching across quality, efficacy and safety.
- The biosimilar adalimumab submission included clinical data from pharmacokinetic (PK) studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis[1].
- The biosimilar infliximab submission included clinical data from a PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis[2].
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and following positive CHMP opinions for biosimilars rituximab and etanercept (April 2017), it is on track to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
* Humira® is a registered trademark of AbbVie Biotechnology Ltd.
** Remicade® is marketed by MSD in Europe and is a registered trademark of Janssen Biotech, Inc.
*** Sandoz press release https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilars-rituximab-and-etanercept-recommended-approval-europe (last accessed 28 April 2017)
Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 31 countries that form the European Economic Area (EEA) in February 2016 where it is known as GP1111. Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.
References
- Blauvelt A et al. A randomized, double-blind, multicenter study to compare
the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
- Pfizer Inc. Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab). Available at:http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_remicade_infliximab (last accessed 05 May 2017).
SOURCE: Sandoz
Post Views: 205
- Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira®* and Remicade®**
- Comprehensive data packages demonstrate each biosimilar matches its respective reference medicine in terms of quality, efficacy and safety
- These regulatory submissions follow soon after two positive CHMP opinions*** for Sandoz biosimilars etanercept and rituximab further reinforcing Sandoz immunology pipeline and the broader Novartis immunology portfolio
HOLZEKIRCHEN, GERMANY I May 31, 2017 I Sandoz, a Novartis division, and the pioneer and global leader in biosimilar medicines announced today that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab) both of which are used to treat immunological diseases. Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.
“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited” said Mark Levick MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline”.
The comprehensive data packages included in the EMA submissions demonstrate biosimilarity of the proposed biosimilars to their respective reference medicines, with analytical, preclinical and clinical data matching across quality, efficacy and safety.
- The biosimilar adalimumab submission included clinical data from pharmacokinetic (PK) studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis[1].
- The biosimilar infliximab submission included clinical data from a PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis[2].
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and following positive CHMP opinions for biosimilars rituximab and etanercept (April 2017), it is on track to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
* Humira® is a registered trademark of AbbVie Biotechnology Ltd.
** Remicade® is marketed by MSD in Europe and is a registered trademark of Janssen Biotech, Inc.
*** Sandoz press release https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilars-rituximab-and-etanercept-recommended-approval-europe (last accessed 28 April 2017)
Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 31 countries that form the European Economic Area (EEA) in February 2016 where it is known as GP1111. Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.
References
- Blauvelt A et al. A randomized, double-blind, multicenter study to compare
the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
- Pfizer Inc. Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab). Available at:http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_remicade_infliximab (last accessed 05 May 2017).
SOURCE: Sandoz
Post Views: 205
