Dosage Forms

Amy Ritter was Scientific Editor, BioPharm International.

Articles

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

For Biosimilars, No “One Size Fits All”

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Are biosimilars the next big thing or just the next big bubble?

Biosimilars or Bust

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.

Bipartisan Bill Introduced to Encourage Generic Drug Use in Medicaid

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

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

FDA and Manufacturers Ponder Biosimilars Pathway

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Merck to Develop Biosimilar with Korean Chemical Manufacturer

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

Advocating for Biosimilar Approval Standards Under BPCI

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

Regulatory Roundup: FDA asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications

Innovator and generic-drug companies need to adapt to compete in the biosimilars market.

Manufacturing Strategies for Biosimilars

The IMS institute has released its report on the use of medicines in the United States during 2010.

IMS: Growth in Drugs Stalls, Generic Use Up

Increased competition, the rising role of emerging markets, and targeted opportunities in niche segments are factors influencing the generic-drug market and related supply base.

Generic Drugs