Generic Drugs

FDA Releases REMS Guidance

May 31, 2018

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

FDA Commissioner Puts Branded Companies on Notice

May 17, 2018

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

China’s Pharma Growth Potential to Drive Attendance at CPhI China

May 17, 2018

Internationalization and regulatory reform are driving growth and investment China.

Gottlieb Encourages Biosimilars and Safer Opioid Packaging

February 08, 2018

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

Opportunities and Obstacles for Generic Drugs

February 02, 2018

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

CPhI Report Predicts A Transformative Year for Japan in 2018

January 25, 2018

Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.

Hospitals Launch Their Own Generic Drug Company

January 19, 2018

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

GAO Report Calls for FDA to Publicly Announce Guidance on Nonbiological Complex Drugs

January 16, 2018

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

FDA Releases ANDA Submission Guidance

January 03, 2018

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

December 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.