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Regulatory considerations for biosimilar analytical similarity assessments

Drug Patent Watch

Regulatory Considerations for Biosimilar Analytical Similarity Assessments Biosimilars, or follow-on biologics, are biopharmaceuticals that are highly similar to an already approved biological product.

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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. link] KBDNA. 2024, May 17). link] Lawless, L.

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Analyzing the impact of biosimilars on biologic drug development pipelines

Drug Patent Watch

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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Biosimilar clinical trials and study designs’ considerations

ProRelix Research

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.

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The impact of biosimilars on biologic drug distribution models

Drug Patent Watch

The introduction of biosimilars has significantly altered the landscape of biologic drug distribution models. Biosimilars, which are highly similar to […] Source

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Cracking the Biosimilar Code: A Deep Dive into Effective IP Strategies

Drug Patent Watch

In the rapidly evolving landscape of biosimilars, intellectual property (IP) strategy is paramount. Biosimilar manufacturers face unique challenges, including navigating […] Source

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The role of biosimilars in reducing out-of-pocket costs for patients

Drug Patent Watch

Breaking Down Barriers to Affordable Healthcare: The Power of Biosimilars As we navigate the complex landscape of modern healthcare, one thing is clear: the cost of prescription medications is a significant burden for many patients. So, how do biosimilars work? But the benefits of biosimilars extend far beyond individual patients.