Samantha DiGrande

October 11, 2018

Coherus BioSciences has launched a comprehensive website offering patients and providers support services for its biosimilars.

October 10, 2018

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

October 09, 2018

Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

October 08, 2018

The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.

October 06, 2018

The United States House of Representatives has passed the Patient Right to Know Drug Prices Act. The bill will now be sent to the President for his consideration, as the Senate already passed the bill earlier last month with an overwhelming majority of 92 to 2.

October 05, 2018

Merck’s infliximab biosimilar, sold as Renflexis and approved by the FDA in April of last year, was determined to be the lowest priced infliximab option available to the US Department of Veterans Affairs (VA), and was awarded a national contract. Subsequently, it has become the sole infliximab product available on the VA's National Formulary.

October 04, 2018

Tanvex BioPharma, a Taiwan-based biopharmaceutical company, announced this week the submission of its Biologics License Application (BLA) to the FDA for TX-01, a proposed filgrastim biosimilar referencing Neupogen.

October 03, 2018

The Association for Accessible Medicines (AAM) and the Biosimilars Council (a division of AAM) have submitted comments to the FDA in reference to its Biosimilar Action Plan.

October 02, 2018

This guidance document comes after AllTrials, an international initiative, launched a tracking tool in February 2018 that publicly discloses which research entities have not reported data from clinical trials.

October 01, 2018

The poll found that 82% of Republicans, 92% of Democrats, and 91% of Independents polled supported legislation to limit nonmedical switching.