Benepali has become the first biosimilar of Amgen’s Enbrel (etanercept) approved in Europe and marks the first regulatory success for Samsung Bioepis – a joint venture between Samsung Biologics and Biogen.
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) today revealed plans to remove market barriers to biosimilars and small molecule generics and create thousands of jobs.
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).
Under the bill first proposed in 2014, which won unanimous approval last week from a New Jersey Assembly committee, pharmacists would have to notify prescribers within five days of dispensing an interchangeable biosimilar.