Generic Drugs

Guidance Answers Questions on GDUFA

July 25, 2017

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

Eli Lilly Resolves Patent Litigation Over Cialis

July 12, 2017

The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.

Biosimilars Overcome Legal and Analytical Hurdles

July 05, 2017

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

FDA Acts to Improve Market Competition

June 27, 2017

The agency announced it is taking steps to increase competition within the prescription drug market.

EMA Recommends Approval for Eight New Drugs, One Biosimilar

June 23, 2017

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

FDA Announces Public Meeting on Generic Drugs

June 21, 2017

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

Continuous Manufacturing: A Generic Industry Perspective

May 30, 2017

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

FDA Releases New and Revised Product-Specific Generic Drug Guidance

May 16, 2017

The agency released several new and revised guidance documents regarding product-specific generic drug development.

Cost Considerations Drive Lean Technology in Biomanufacturing

May 15, 2017

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

EMA Promotes Understanding and Use of Biosimilars

May 05, 2017

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