Generic Drugs

Celltrion Announces that Remicade Biosimilar Could Save Up to $380 Million USD

February 23, 2015

Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.

Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar

February 11, 2015

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Mylan Partners with Theravance to Develop an Investigational Treatment for COPD

February 03, 2015

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

Ligand-Binding Assays and the Determination of Biosimilarity

February 02, 2015

Ligand-binding assays are fundamental to characterizing biosimilars.

Labeling of Biosimilars

February 02, 2015

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Gauging the CMO Biosimilar Opportunity

February 02, 2015

Market forces may limit the success of CMOs.

FDA Advisors Unanimously Approve Sandoz Biosimilar

January 08, 2015

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Biosimilar Development Moves Forward at FDA

December 19, 2014

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

PTSM: Pharmaceutical Technology Sourcing and Management

Generic Drugs Face New Regulatory Future

December 01, 2014

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

FDA Requests Comments on Generic Drug Submission Criteria

November 20, 2014

FDA opens public docket on proposed criteria for “first generic” ANDAs.