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EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.


EMA Promotes Understanding and Use of Biosimilars

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

Sandoz’s Rituximab and Etanercept Biosimilars Recommended for European Approval

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

EDQM Clarifies the Role of Monographs in Determining Biosimilarity

Aurobindo has added four cell-culture derived biosimilars to its product line.

Aurobindo Adds Four Biosimilars From TL Biopharmaceutical

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.

AbbVie: Despite Competition, Humira Still the Number-One Prescribed Biologic

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

EMA Recommends Approval of Two Biosimilars

A pilot project, beginning in 2017, will support the development of biosimilars.

EMA Launches Biosimilars Project

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

EMA Recommends Approval of Three Biosimilars

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Manufacturing, Biosimilars and Biobetters