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.
At least 80% of patients currently taking AbbVie’s blockbuster drug could be switched to “the best value biological medicine” within 12 months, according to the UK National Health Service.
Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.
Nurses can take the lead when ‘making the switch’ between an originator and biosimilar medicine, says nurse practitioner Hanneke Voorneveld-Nieuwenhuis.
A prequalification pilot designed to assess biosimilar versions of Roche’s Rituxan and Herceptin has attracted global interest from manufacturers, says WHO executive.
