There is no evidence for adverse effects due to a switch from a reference product to an approved biosimilar and the “theoretical basis of such adverse effects is weak,” according to the latest statement on biosimilars from the Finnish Medicines Agency Fimea.
Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.
As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’ research models.
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.