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Biosimilars 2.0: guiding principles for a global "patients first" standard
Joseph Miletich1, Geoffrey Eich, Gustavo Grampp
1Amgen Inc., Thousand Oaks, CA, USA.
Mabs
|April 23, 2011
Summary
The first era of biosimilars (Biosimilars 1.0) focused on simpler proteins. Biosimilars 2.0 will involve complex medicines, requiring rigorous evaluation and global standards for improved patient access.
Area of Science:
- Biopharmaceuticals
- Drug Development
- Regulatory Science
Background:
- European Union biosimilar approvals began in 2006 via an abbreviated pathway.
- Early biosimilars (Biosimilars 1.0) were based on well-understood endogenous proteins.
- These products often had complex safety and immunogenicity profiles.
Purpose of the Study:
- To define the characteristics and challenges of the upcoming era of biosimilar development, termed Biosimilars 2.0.
- To outline the necessary standards and collaborative efforts for successful Biosimilars 2.0 implementation.
- To facilitate increased patient access to advanced biological medicines.
Main Methods:
- Review of historical biosimilar approval pathways and product types.
- Analysis of trends in pharmaceutical development for complex biologics.
- Identification of key considerations for future biosimilar regulatory and manufacturing standards.
Main Results:
- Biosimilars 2.0 will focus on complex reference products for cancer and autoimmune diseases.
- This era necessitates global harmonization of standards and increased long-term monitoring.
- High fidelity to reference products and rigorous analytical, non-clinical, and clinical evaluations are critical.
Conclusions:
- Biosimilars 2.0 presents an opportunity for advanced medicines, demanding high product quality and manufacturer accountability.
- Transparency in labeling and accountability to patients and providers are essential.
- Partnership between healthcare, industry, and regulators is crucial to establish appropriate standards for increased access and patient needs.
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