Dosage Forms

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Articles

Pfizer has signed an agreement with the Chinese biopharmaceutical company Zhejiang Hisun Pharmaceuticals with the objective of establishing a $545-million joint venture to develop and commercialize branded generic medicines in both China and the global market.

Pfizer, Zhejiang Hisun Pharmaceuticals Sign Generic-Drug Deal

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

Global Market Boom for Generic Drugs

AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More.

Week of Dec. 26, 2011: AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung's latest effort to strengthen its position in biosimilars.

Biogen Idec, Samsung Form Biosimilars Joint Venture

Amy Ritter was Scientific Editor, BioPharm International.

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

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

EMA Invites Feedback on Biosimilar and Vaccine Concept Papers

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

Generic Drug User Fee Agreement Nears Completion

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.