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Patenting and Regulatory Aspects of Biosimilars

Introduction to Biosimilars

Biosimilars are biologic products that are highly similar to the reference product notwithstanding minor differences in clinically inactive components.

The legislation introduced an abbreviated pathway for biosimilars versions of US Food and Drug Administration (FDA) licensed reference products.

What is Patentable from a Biosimilar?

While our study found that many secondary patents are at issue in biosimilar efforts to enter the US market, this study evaluates the frequency of terminal disclaimers filed by drug patent holders to obviate double patenting rejections.

This paper begins by reviewing the nature of biologics the rules of biologics patent litigation and the governing regulatory framework.

Europes Leading Patent Law Firms 2021