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Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review

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Copyright © DrugPatentWatch. Originally published at

A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.

Over the past three decades, biotherapeutics have revolutionized healthcare by providing effective treatments for complex diseases that were previously challenging to manage with traditional small molecule pharmaceuticals. With the expiration or imminent expiry of patents on several biotherapeutics, the market for biosimilars has witnessed remarkable growth. Biosimilars are products deemed similar to already-approved innovator products in terms of safety and efficacy. However, the production of biosimilars presents unique complexities, as the manufacturing process itself is the product. Small variations in the biotech processes can lead to significant undesirable clinical effects. Consequently, regulatory authorities worldwide have established stringent guidelines to ensure the safe approval of biosimilars.

This article offers a thorough review of unsuccessful regulatory filings for biosimilar approval. Focusing on regulatory submissions to the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the United States, the authors identify and discuss key shortcomings in these filings, which resulted in non-approval.

Key Points

The review presents an overview of the status of approved biosimilars in Europe and the US, providing valuable insights into the growing significance of these products in the healthcare landscape. By analyzing unsuccessful regulatory filings, the authors shed light on the challenges faced by developers during the approval process. Notably, the review delves into the critical issues that contributed to the lack of approval, offering essential lessons for future developers and regulatory professionals in the field of biosimilars.

The article provides valuable insights into the world of biosimilars and their regulatory challenges. By examining the shortcomings of unsuccessful regulatory filings, the review contributes to a better understanding of the intricacies involved in the approval process. These insights are expected to aid researchers, developers, and regulatory authorities in devising more effective strategies and ensuring the successful approval of biosimilars, thereby fostering better access to safe and cost-effective biotherapeutic treatments for patients worldwide.

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Copyright © DrugPatentWatch. Originally published at
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