Biosimilars and Biobetters

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

Fresenius Kabi enters biosimilars market with acquisition of Merck KGaA’s Biosimilars Business

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

A controversial naming convention attempts to explain important distinctions between biologic drugs and their biosimilar counterparts.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

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FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.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