Biosimilars and Biobetters

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

FDA advances biosimilars progress with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

Method choice is crucial to when seeking answers to biosimilar characterization questions.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

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.