Decision Resources Group found that sales of biosimilar versions of the granulocyte colony-stimulating factors (G-CSFs) filgrastim and pegfilgrastim could reach $1.8 billion in the United States by 2023.
DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at the impact of the Hatch-Waxman act and Q&A's with industry leaders, in this multi-page report.
A new study published Thursday by the Center for Healthcare Supply Chain Research identifies factors, based on an analysis of European models, that may affect the American launch of biosimilars and their marketplace potential in the United States.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
Roche on Wednesday announced that Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego.
As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.
Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.
Teva Pharmaceutical and Labrys Biologics, a privately-held development stage biotechnology company focused on treatments for chronic migraine and episodic migraine, on Tuesday announced that Teva has entered into a definitive agreement to acquire Labrys in a deal for $200 million in upfront payment in cash at closing as well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.
The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.
The pace of annual global spending on oncology medicines — which is approaching the $100 billion threshold — has moderated over the past five years, even as a surge in innovative and targeted therapies has brought new therapeutic options to the growing number of patients being treated for cancer and as survival rates for most tumor types continue to increase, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics.
The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.