Generic Drugs

State Legislatures Become Battlegrounds for Biosimilars

April 11, 2013

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products

Teva and Lonza Review Biosimilars Opportunity

April 08, 2013

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Prescribing Caution for Biosimilars

April 02, 2013

Sound policies are needed to govern the substitution of interchangeable biologics.

Mylan Acquires Generic Injectables Unit From Strides Arcolab

March 05, 2013

Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash.

Merck and Samsung Bioepis Form Biosimilars Development and Commercialization Agreement

February 20, 2013

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Product Analysis Key to Biosimilar Development

November 02, 2012

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

EU Sets Guidelines for Biosimilar Monoclonal Antibodies

November 02, 2012

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

AET BioTech and BioXpress Therapeutics to Codevelop Adalimumab Biosimilar

October 30, 2012

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.

New Era for Generic Drugs

October 02, 2012

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

EMA Aims to Facilitate Biosimilars Development

October 01, 2012

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.