Biogen agrees Nightstar acquisition for $800m to take on its pipeline of AAV treatments for retinal disorders, diversifyingy its pipeline in the rare disease market.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
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.
In another blow to discovering a treatment for Alzheimer’s, Roche revealed that preliminary data from two clinical trials meant it was cancelling studies using crenezumab.
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.
Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.
A prequalification pilot designed to assess biosimilar versions of Roche’s Rituxan and Herceptin has attracted global interest from manufacturers, says WHO executive.
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.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
Vendors say they are open to considering a singular, industry-wide design for disposable bioreactor equipment, IP concerns and customised demands could impede its adoption.
Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).
Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.
Roche has added technology to tailor enzymes for specific applications in next-generation DNA and RNA sequencing through the acquisition of Kapa Biosystems.
To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
Roche has agreed to research, develop and commercialize Inovio Pharmaceuticals' vaccine delivery tech as well as its multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B.
Responding to surging demand for its flu drug Tamiflu, Roche has
announced it is expanding its external contractors to fifteen in
nine different countries, as its needs for intermediates and
finished product increase.
