Allison Inserro

April 02, 2019

Stakeholders testified before a House of Representatives subcommittee about the impact of the rising costs of insulin, while the FDA announced it will hold a public hearing May 13 about its plan to transition follow-on insulins to a regulatory pathway for biosimilars.

April 01, 2019

While policymakers are grappling with ways to reduce to cost of expensive prescription drugs, one of the proposed solutions—targeting rebates negotiated by pharmacy benefit managers (PBMs)—will not on its own be enough to reduce overall pharmaceutical spending, according to a new brief from The Commonwealth Fund.

March 29, 2019

March 2019 kicked off with a surprise, when FDA Commissioner Scott Gottlieb, MD, announced he was leaving the administration. In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.

March 27, 2019

The House Ways and Means Subcommittee on Trade heard testimony this week from labor leaders and others about a revised trade agreement that some say will hurt the biosimilar industry in the United States.

March 27, 2019

The Affordable Care Act was signed into law 9 years ago and created a biosimilars market in the United States, but what could happen if the Trump administration is successful in persuading the Fifth Circuit Court of Appeals to affirm a lower court ruling that the law is invalid?

March 25, 2019

Roche Holding AG has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab (Rituxan).

March 22, 2019

Ontruzant, a biosimilar trastuzumab referencing Herceptin, shows comparable overall survival and cardiac safety, Samsung Bioepis says.

March 21, 2019

As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about the factors holding back biosimilars in the United States.

March 20, 2019

Some stakeholders raised questions about how orphan drugs or biosimilars would be analyzed in the report. The Institute for Clinical and Economic Review's (ICER's) response to both were similar: it did not understand why drugs for orphan diseases or the market entry of biosimilars would lead to rapid price increases.

March 19, 2019

Branded drug products have fewer potential cost-saving limits on them in Medicare Part D formularies, researchers at John Hopkins University have found.