Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Niazi, Sarfaraz K.

doi:10.2147/ceor.s404175

CEOR

2023

DOI: 10.2147/ceor.s404175

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Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Sarfaraz K. Niazi¹

Abstract: Almost two decades since biosimilars arrived, we still await their broader adoption, as anticipated. The roadblocks to this adoption include the high amortized cost of goods due to regulatory burden, hurdles created by the distribution system, perception of safety and efficacy, and lack of focus by stakeholders on removing these roadblocks. In this paper, I analyze the source of these roadblocks and offer practical solutions to remove them. These efforts are needed to maximize the adoption of biosimilars to en… Show more

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2024

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Cited by 2 publications

References 22 publications

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Advancing Therapeutic and Vaccine Proteins: Switching from Recombinant to Ribosomal Delivery—A Humanitarian Cause

Niazi,

Magoola

2024

IJMS

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Recombinant therapeutic and vaccine proteins have revolutionized healthcare, but there remain challenges, as many are awaiting development due to their slow development speed and high development cost. Cell-free in vivo ribosomes offer one choice, but they come with similar constraints. The validation of in vivo messenger RNA (mRNA) technology has been accomplished for COVID-19 vaccines. The bioreactors inside the body, the ribosomes, deliver these proteins at a small cost, since these are chemical products and do not require extensive analytical and regulatory exercises. In this study, we test and validate the final product. A smaller fraction of the recombinant protein cost is needed, removing both constraints. Although thousands of in vivo mRNA products are under development, their regulatory classification remains unresolved: do they qualify as chemical drugs, biological drug, or gene therapy items? These questions will soon be resolved. Additionally, how would the copies of approved in vivo mRNA protein products be brought in, and how would they be treated: as new drugs, generic drugs, or new biological drugs? Researchers are currently working to answer these questions. Regardless, these products’ cost of goods (COGs) remains much smaller than that of ex vivo mRNA or recombinant products. This is necessary to meet the needs of the approximately 6.5 billion people around the world who do not have access to biological drugs; these products will indeed serve the dire needs of humanity. Given the minor cost of establishing the manufacturing of these products, it will also prove financially attractive to investors.

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Advancing Therapeutic and Vaccine Proteins: Switching from Recombinant to Ribosomal Delivery—A Humanitarian Cause

Niazi,

Magoola

2024

IJMS

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Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products

Niazi

2024

Pharmaceutics

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Pharmacopeia monographs are not intended to establish biosimilarity. However, the US Food and Drug Administration (FDA) has stopped the US Pharmacopeia (USP) from creating monographs for biological drugs due to the need for side-by-side comparisons with the reference products. The USP can create Biological Product Specifications (BPS), not to be labeled as monographs, based on the analytical testing of reference products and validated test methods that will remove the need for side-by-side analytical testing of biosimilars with reference products. Scientific arguments confirm that this plan is logical and capable of creating global quality standards for biosimilars to allow their interchangeability with other biosimilars. While the regulatory agencies have waived many high-cost biosimilar tests, analytical assessment is the most sensitive test; reducing its cost will further enhance the entry of biosimilars with no clinically meaningful difference.

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Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Cited by 2 publications

References 22 publications

Advancing Therapeutic and Vaccine Proteins: Switching from Recombinant to Ribosomal Delivery—A Humanitarian Cause

Advancing Therapeutic and Vaccine Proteins: Switching from Recombinant to Ribosomal Delivery—A Humanitarian Cause

Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products

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