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A pilot project, beginning in 2017, will support the development of biosimilars.

EMA Launches Biosimilars Project

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

Reliable, high-quality products require innovative analytics and production.

Biosimilars to Drive Modern Manufacturing Approaches

The biosimilar pathway permits licensure based on less than full clinical data.

FDA Advises Limited Clinical Testing for Biosimilars

Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.

Xellia Pharmaceuticals Expands R&D in Croatia

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Outlook for Biosimilars in 2020

Alan Sheppard, Principal, Global Generics at IMS Health and CPhI expert panel member, discusses generic medicine opportunities in the 2016 CPhI Annual Industry Report.

Generic Medicines Provide Growth Opportunities

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

Keeping Generics Relevant: a Wish List from Dilip Shah

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA Approves Humira Biosimilar

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

FDA Releases Guidance on GDUFA Self-Identification

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

Generic Drugs