Dosage Forms

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Pfizer, Merck, Sanofi, and AstraZeneca are among the companies reporting revenue declines from generic-drug incursion. A look at what the companies are doing to stimulate growth.

Pfizer, Merck, Sanofi, and AstraZeneca Facing the Generic-Drug Squeeze

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Demonstrating Biosimilarity

FDA releases FY 2014 generic-drug user fees.

FDA Publishes Generic-Drug User Fees

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

FDA funds research to further development of innovative generics, while working to address review and approval issues.

Generic Drugs Face Regulatory and Scientific Challenges

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

CHMP Recommends Approval of First Two mAb Biosimilars

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

Sandoz Launches Phase III Clinical Trial for Biosimilar Etanercept

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

EMA Revises Biosimilars Guideline

Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market.

Report Previews Future of U.S. Biosimilar Market

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

Cipla Launches First Biosimilar of Etanercept in India for Rheumatic Disorders

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

The FDA approved updated labeling for Purdue Pharma L.P.?s reformulated OxyContin tablets, but also determined that it will not approve generic versions of the original OxyContin.