The Center for Biosimilars Staff

July 08, 2017

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

July 07, 2017

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

July 07, 2017

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 3, 2017.

July 06, 2017

A recent study, published in Transfusion, analyzed 3 granulocyte-colony-stimulating factor treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.

July 05, 2017

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

July 04, 2017

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

July 03, 2017

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

July 02, 2017

As of July, 2017, 33 US states and Puetro Rico have enacted laws concerning biosimilar substitution.

June 30, 2017

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of June 26, 2017.

June 29, 2017

Celltrion and Teva announced today that the FDA has accepted the companies’ Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar. FDA regulatory action is expected in early 2018.