Dosage Forms

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Articles

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

CDER to Expand Office of Generic Drugs

Amy Ritter was Scientific Editor, BioPharm International.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

Pfizer and Mylan Partner to Develop Generic Drugs in Japan

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

Market Strengths and Weaknesses in Biosimilars

Sandoz announced it has completed the acquisition of Fougera Pharmaceuticals, a maker of generic dermatology products, for $1.5 billion.

Sandoz Completes Acquisition of Generic Dermatology Company Fougera for $1.5 Billion

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

Congress Passes Generic Drug Act

Basilea, Stiefel Enter into Hand-Eczema Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More.

Week of June 11, 2012: Basilea, Stiefel Enter into Hand-Eczema Treatment Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Dr. Reddy's and Merck Serono Team Up on Biosimilars

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Looking for Fingerprints: Bioanalytical Characterization of Biosimilars

Does global development have to entail multiple comparability studies?

Biosimilar Developers Face a Reference-Product Dilemma

Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.