Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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

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

Amy Ritter was Scientific Editor, BioPharm International.

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

Sean Milmo is a freelance writer based in Essex, UK.

Poland's government aims to make the Eastern European country a biotech powerhouse.

Report from Poland

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

GPhA Urges Congress to Move Ahead on Generic-Drug and Biosimilar User Fees

Angie Drakulich was editorial director of Pharmaceutical Technology.

Has the long-awaited guidance answered all of the industry's questions?

FDA Guides the Way to Biosimilars in the US

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

FDA Announces Public Meeting to Discuss Biosimilar User Fees

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

Biosimilars' Technology Needs

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.

Manufacturing, Biosimilars and Biobetters