Samantha DiGrande

August 09, 2018

Celltrion’s Korean plant has received its second Form 483 from the FDA in less than a year, only months after having received a warning letter for the same facility.

August 08, 2018

Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.

August 07, 2018

The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.

August 06, 2018

Stada, a biopharmaceutical company based in Germany, recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.

August 04, 2018

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

August 03, 2018

The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.

August 02, 2018

Vizient, a healthcare performance improvement company, recently released its Drug Price Forecast Highlights biannual report that provides an estimate of the change in the cost of medicines for 2019.

August 01, 2018

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

July 31, 2018

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.

July 30, 2018

This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.