Biosimilars and Biobetters

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

Development requirements and regulatory guidance for biosimilars and biobetters.

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

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

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.

Understanding opportunities and challenges across all major phases of development.

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Does global development have to entail multiple comparability studies?

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

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

The author explains the current status of India, the challenges, and recommendations that may alleviate these challenges.

Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.

The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

Are biosimilars the next big thing or just the next big bubble?

Follow-on versions of complex biologics require extensive expertise.

The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?

An in-depth analysis of the patent provisions of the new legislation.

The third holy grail of biosimilars: interchangeability.

Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.

The new US legislation will forever alter the commercial landscape for biologics.

New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

The new patent regime is challenging the Indian biopharm industry to transition from generics to novel products.