Fuji Pharma signs agreement to receive an exclusive supply of the ustekinumab biosimilar for the Japanese market, furthering a previous investment agreement.
Korean authorities continue to place pressure on the CDMO, after prosecutors raided the office of the national stock exchange regarding behaviour preceding the public listing of Samsung BioLogics.
A judge has ruled in favour of AbbVie, finding that Boehringer should disclose its US launch plans for its Humira biosimilar if it wants to prove patent protection inhibited its commercial release.
Celltrion Healthcare’s head of medical and marketing outlines how the US biosimilar market is evolving and how manufacturing efficiency could become a key distinguisher from competitors.
Pfizer’s Zirabev receives approval from the European Commission as a biosimilar to Roche’s Avastin, which brought in sales of CHF1.8bn in Europe during 2018.
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.
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.
Pfizer has launched the first biosimilar to J&J’s Procrit and Amgen’s Epogen in the US at a ‘significant discount’ to competitors’ wholesale acquisition costs.
Unlike the European system, manufacturing authorisation holders in Jordan must own or operate from a manufacturing facility to apply for biosimilar approval, says JFDA executive.
As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
Within days of Samsung Bioepis sending its Soliris candidate to the clinic, the firm details its development process, novel biologics ambitions, and plans to become ‘the single dominant player in biosimilars’.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
