ISSUE NO. 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies
Biologics have become the fastest-growing class of therapeutic compounds, with seven of the top-10 selling drugs in 2023 being biologics, each exceeding sales of $10 billion USD. In 2022, biosimilars accounted for 13.7% of all spending on biologics, compared with the 8.9% in 2021.
Biologics have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders.
A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It enters the market subsequent to the patent expiration of a previously authorized version of a biologic. A biosimilar is approved only after showing that it is “highly similar” to an approved biological product, known as the reference product, in terms of structure, purity, potency, safety, pharmacokinetics, and in many cases, efficacy, with allowable minor differences.
In Issue 4 of The Altascientist, learn about the growing interest of biosimilars, and key considerations in pharmacokinetic (PK) studies, as well as:
• The rise of the biosimilar market
• The regulatory landscape
• How Altasciences puts biosimilars to the test
• Altasciences’ expertise in bioanalysis
• Key considerations for biosimilar clinical pharmacology studies
• Ensuring the continued success of biosimilar programs
Considerations and Study Challenges for Biosimilars
Early awareness of study challenges is crucial in running a successful early-phase biosimilar development program, and certain considerations must be taken into account before beginning a study.
Recruitment is often one the most challenging aspects of the biosimilar clinical trial process and can lead to trial delays if not managed effectively. The inclusion and exclusion criteria for healthy participants in a biosimilar bioequivalence study are often much stricter than a standard bioequivalence study on a small molecule.
Additionally, as a biosimilar product is not exactly the same as the reference product, there are also increased safety risks associated with the administration of the test product. Key safety considerations include immunogenicity, hypersensitivity reactions, and an increased risk for other adverse effects.
How Altasciences Can Support Your Biosimilar Drug Development
Bioanalytical considerations are another important factor. Unlike small molecule drugs, biologics exhibit a significant level of complexity which is driven by the fact that their production is dependent on a living system, such as a microorganism, a plant, or animal cells.
Altasciences supports method development, GCP/GLP-compliant biosimilar assay development validation, and sample analysis for PK and immunogenicity/anti-drug antibody (ADA) testing, and we are proud of our bioanalytical expertise with LC-MS/MS and ligand binding platforms . We provide support for all stages of drug development (discovery to preclinical to Phase IV) for both small and large molecules programs.
“Altasciences has the perfect mix of innovator and generic drug development experience, with a thorough understanding of the regulatory complexities involved in biosimilar clinical pharmacology studies. Companies developing biosimilars are collaborating with us because of our firsthand experience, distinctive recruitment strategies, and speed in conducting biosimilar clinical trials that require a customized approach based on the therapeutic indication and study-specific goals. Our expertise allows us to accelerate our clients’ biosimilar development programs so they can offer greater treatment options and more cost-effective medications to patients in need.”–Danielle Salha Senior Director, Global Immunology, Ligand Binding Assays
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