Generic Drugs

Unilife to Supply Hikma with Prefilled Syringes for Generic Injectables

November 22, 2013

Unilife to begin commercial supply in 2014.

Generic Drug Super Office Takes Shape

November 08, 2013

Generic Drug Super Office Takes Shape

California Governor Jerry Brown Vetoes Biosimilar Bill

October 16, 2013

Governor Jerry Brown cites physician notification requirements for dispensing biosimilars as premature in the absence of FDA specifications for interchangeability.

Elucidating Biosimilars Characterization

October 02, 2013

Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.

First biosimilar mAb approved in Europe

September 13, 2013

Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.

California State Senate Passes Biosimilars Bill

September 06, 2013

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Baxter and Coherus Biosciences Collaborate On Biosimilars

September 05, 2013

Baxter and Coherus Biosciences colaborate to develop and commercialize a biosimilar version of etanercept for Europe, Canada, and, Brazil.

The Importance of Characterization in Biosimilars Development

September 02, 2013

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance

August 28, 2013

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Oncobiologics and InVentive Health Clinical Form Biosimilars Pact

August 07, 2013

The companies initially focused on five biosimilar products.