Manufacturing, Biosimilars and Biobetters

Modest Expectations for CMOs and Biosimilars

March 03, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.

Johnson & Johnson’s Remicade Patent Invalidated

February 20, 2015

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

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.

India—A Force to be Reckoned with in Pharmaceutical Manufacturing

December 02, 2014

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

FDA Accepts First Biosimilar Filing

July 24, 2014

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

FDA Releases Draft Guidance on Biosimilarity

May 14, 2014

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.