Biosimilars and Biobetters

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

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

Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.

What will manufacturers have to do to ensure the continued uptake of biosimilars?

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

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

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

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

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

R-Pharm Group, a private Russian pharmaceutical company, has opened a biopharmaceutical production plant in Yaroslavl, Russia, to produce biologics and biosimilars to treat autoimmune diseases and cancer. The facility, which has a line capacity is 2,000 L of cell culture per production cycle, is ready to be validated to US and Russia FDA and GMP requirements, the company reports.

CPhI outlines trends from the conference in Seoul.

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

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.