Health Canada opts not to include the additional suffix after biologics’ non-proprietary name, instead relying on the brand name and products’ identification number.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
The US market for insulin biosimilars is set to open up in 2020, and the head of biopharmaceuticals at Sandoz explained why he is confident of an ‘acceleration’ of the US biosimilar market in the coming years.
Active competition law enforcement is encouraging the pharmaceutical industry to provide more affordable medicines and promotes innovation, suggests EC report.
The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
2018 saw an increase in the number of biosimilar approvals, and the expiry of patents on major products that allowed the entry of biosimilars across Europe.
The US regulator has validated Celltrion and Teva’s biosimilar version of Roche’s Herceptin, marking the partnership’s second approval in as many months.
