Business

Trump Administration Withdraws Proposed Rule to Block Rebates

July 11th 2019

By The Center for Biosimilars Staff

The Trump administration has withdrawn its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations.

A Q&A With Goodwin's Alexandra Valenti, JD, About Patent Discussions in the Senate

July 10th 2019

By Allison Inserro

The Center for Biosimilars® had a conversation with Alexandra D. Valenti, JD, of Goodwin’s Intellectual Property Litigation group, to help understand the recent discussions in the Senate Judiciary Committee about ongoing attempts at patent reform.

Research Finds "Significant Association" Between Pharma Payments to Prescribers and Biologic Spending in Medicare

July 10th 2019

By Kelly Davio

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

FDA Issues Another Form 483 to Biocon Over Its Insulin Facility

July 9th 2019

By Kelly Davio

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

Judge Vacates Administration's Rule on Drug Prices in Advertising

July 9th 2019

By Kelly Davio

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.

Prestige BioPharma Strikes 2 More Deals for Biosimilar Trastuzumab, HD201

July 8th 2019

By The Center for Biosimilars Staff

Singapore-based Prestige BioPharma has entered into 2 new agreements related to its proposed biosimilar trastuzumab, HD201, which it hopes to sell under the brand name Tuznue.

Samsung Bioepis Gains EU Label Update for Biosimilar Adalimumab, Imraldi

July 8th 2019

By Kelly Davio

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

Eye on Pharma: Bio-Thera's Adalimumab Biosimilar Meets Primary End Point in Phase 3 Study

July 4th 2019

By The Center for Biosimilars Staff

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

European Commission Approves Alexion's Ravulizumab for PNH

July 3rd 2019

By The Center for Biosimilars Staff

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

The Top 5 Biosimilars Articles for the First Half of 2019

July 3rd 2019

The Center for Biosimilars® recaps the 5 most-read stories of 2019 to date.