Amgen and Novartis (parent company of Sandoz, a leader in the biosimilars field) have both come out in support of a set of principles on biosimilars laid down by a coalition of 19 institutional investors.
The investor principles, which are included in the coalition’s Investor Statement on Board Oversight of Biosimilar Issues, aim to guide corporate boards on policy and oversight responsibilities related to biosimilar activities. In particular, they call on boards to ensure that information provided to policymakers on patient safety is balanced, investor dollars used for political lobbying is aligned with shareholder interests and disclosure on significant business partnerships is transparent.
The principles are part of an ongoing initiative, led by the UAW Retiree Medical Benefits Trust, to engage 25 of the largest pharmaceutical companies on the issue of biosimilars.
The investor coalition is therefore urging boards of directors to use the following principles to guide decision-making related to biosimilars:
- Policy and educational information provided on biosimilars should be balanced, accurate and informed by the patient safety experience of biosimilars in the EU and other biosimilar markets.
- Lobbying expenditures for federal and state activities related to biosimilars should be fully disclosed and boards should ensure that political activities are aligned with investor and other stakeholder interests.
- Key information about any partnership or business deal related to biosimilars should be fully disclosed to investors, including information about the value, terms and duration of the deal.
Amgen has affirmed these three principles as a guide to decision-making relating to biosimilars and has stated that their business already adheres to these three principles.
The investor principles also discuss the contentious issue of naming of biosimilars, stating that the information being disseminated is imbalanced. They point to the safety record of the 14 biosimilars that have been marketed in the European Union (EU) since 2006. They also point out that data from companies that currently market biosimilars in Europe show no immunogenicity issues, an assertion affirmed by Member States of the EU and the European Medicines Agency.
Amgen’s view on the other hand is that biologicals (including biosimilars) should have distinguishable names. Amgen says that the company feels ‘strongly that all biologic[al] medicines need a distinguishable component in their non-proprietary (proper) name. This means that patients, caregivers, healthcare professionals, regulators and industry can more readily and accurately identify, investigate and report adverse events’ [1]
On 24 July 2014, Sandoz became the first company to file for US biosimilar approval by the US Food and Drug Administration under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 [2].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars naming debate intensifies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-naming-debate-intensifies
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application
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Source: Amagen, UAW Retiree
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