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Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

US Prescription Drug Spending to Hit $610 billion in 2021, according to Quintiles/IMS

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

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

Former CDER OSI Associate Director for Risk Science to Speak at CPhI North America 2017

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

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

More Generic Drug Approvals Not Enough

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

FDA’s Office of Generic Drugs Releases Annual Report

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

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

GPhA Rebrands as AAM

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.

Dr. Reddy's Expands European Operations

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