As of last year, biotech products accounted for 71% of the revenue generated by the top 10 pharmaceutical-biotech products, according to a new report from the Tufts Center for the Study of Drug Development.
Daniel Galbraith By Daniel Galbraith 2013 was a landmark year for the development of biosimilars. With the global acceptance of biosimilars--also called "follow-on biologics" or...
Celltrion executives are manning the defenses this morning, insisting that the Korean biosimilars company did nothing wrong while confirming that they've fielded regulatory queries about possible insider trading. The allegations come at a particularly awkward time for Celltrion.
Today the European Commission made healthcare history with its first approval of a biosimilar antibody--Inflectra (infliximab)--which was developed by Korea's Celltrion and will be sold by generics powerhouse Hospira. But the companies don't expect to file for U.S. approval until 2015 as they wait for the FDA to finalize its regulatory pathway.
Amgen has won a key victory in its coast-to-coast campaign to persuade state legislatures to require a pharmacist to notify doctors any time they substitute a biosimilar for a branded biologic.
Now that the Swiss drugmaker has decided to forego a patent fight over the breast cancer drug in India, domestic drugmakers are rubbing their hands together in anticipation.
CRO inVentiv Health is teaming up with Oncobiologics to develop biosimilars of some of world's top-selling treatments, signing up to helm clinical trials and help get the knockoffs on the market.
The Cranbury, NJ-based biotech says they will focus on knockoffs of Humira, Rituxan, Avastin, Herceptin and Erbitux.
Lonza Group has bailed out on development of biosimilars and come to a mutual decision with Teva Pharmaceutical to end the two companies' joint venture to advance knockoff biologics. Teva aims to pursue biosimilars development with a "highly selective approach" to picking programs.
Sandoz, the generics arm of drug giant Novartis, launched a Phase III study for its biosimilar of Enbrel with great fanfare today, boasting of a market-leading slate of 7 late-stage biosimilar studies on 5 molecules.