Sentence examples for application for a biosimilar from inspiring English sources

This was not the first application for a biosimilar insulin in the EU.

A number of factors explain biosimilars' failure to launch in the United States, including: confusion about what it means for a biosimilar to be "highly similar" or "interchangeable" with a branded biologic, more than 40 state laws that prohibit automatic substitution of brand-name biologics with biosimilars, a lack of federal guidelines on biosimilar substitution, and confusion over naming.

Regulatory approval for a biosimilar product is provided on the basis of its comparability to an originator product.

Avesthagen (Bangalore, India) has received a patent from the Indian patent office for a biosimilar etanercept [ 7].

Complete an application for a secured card.

application for an examination.

To provide an overview of the underlying scientific principles and standards for developing a biosimilar product.

Therefore, a regulatory framework is in place in, for example, the European Union to assess the application for marketing authorization of biosimilars.

This legislation established a standard for demonstrating that a proposed product is "biosimilar to" the reference biologic as well as a separate standard for demonstrating that a biosimilar is "interchangeable" with the reference biologic [ 7].

This study forms part of an ongoing surveillance programme for epoetin zeta, a biosimilar of epoetin alfa.

The U.S. FDA has retained the discretion to determine whether certain requirements are included in a biosimilar application and recommends a stepwise approach to demonstrating biosimilarity and consideration of the totality of the evidence when reviewing applications.