The bar is set very high in terms of the biosimilar requirement definition, and physicians who are hesitant about substituting biosimilars for treatment should not be worried about the perceived ...

For diseases like diabetes and certain cancers, biologic medicines have revolutionized care for patients. But the complexities around delivering these medicines to patients have resulted in lengthy ...

Biosimilars offer the potential to deliver substantial cost savings in biologic therapy and to contribute to increased patient access to biologic treatments, both of which are particularly relevant ...

Practice-Changing Use of the 21-Gene Test for the Management of Patients With Early-Stage Breast Cancer in Latin America In total, 95% of respondents could identify the most appropriate definition of ...

There is substantial disparity between Medicare Part D and employer-sponsored health insurance plans in the coverage of biosimilars and their reference biologics. These disparities may be due to ...

Biosimilars are often promoted as cost-saving alternatives to their reference medications. Designed to provide comparable therapeutic efficacy at a reduced price, they have the potential to lower ...

Two policy strategies have been pursued to moderate spending on infused cancer biologics. The competition strategy seeks to stimulate market entry by biosimilars, under the principle that newer ...

Tumor Evolutionary Principles: How Intratumor Heterogeneity Influences Cancer Treatment and Outcome Congress passed the BPCI Act on March 23, 2010, as part of the Affordable Care Act. The BPCI Act ...

The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance ...

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service ...