Business

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.

Biologics Are Not Monopolies to Be Regulated, AEI Economists Assert

July 2nd 2019

By Allison Inserro

Two economists from the American Enterprise Institute (AEI) shot back at the idea that biosimilars are natural monopolies and should have their prices regulated by the government, as was proposed a little more than 2 months ago by critics who say that trying to wring lower drug prices through competition born from biosimilars is an experiment doomed to fail.

Amgen Pulls European Application for Its Biosimilar Infliximab ABP 710

July 1st 2019

By The Center for Biosimilars Staff

Amgen says it is withdrawing its European application for ABP 710, its biosimilar infliximab (referencing Remicade).

Eye on Pharma: Egis to Distribute Mundipharma's Pelmeg in Eastern Europe

July 1st 2019

By The Center for Biosimilars Staff

Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia.