Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
The two co-founders of JHL Biotech, Racho Jordanov and Rose Lin, were sentenced by the US Department of Justice for their roles in conspiring to commit trade secret theft and wire fraud.
A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...
Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
The newly separate business will include women’s health, legacy brands, and biosimilar units, as the main part of the business retains oncology, vaccines, hospital and animal health.
Anti-competitive actions by companies hamper uptake of biosimilars, the US FDA suggests, and announces a series of actions that will be taken against them.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
The high growth rate in the uptake of biologics in emerging markets represents a major opportunity for those companies developing biosimilars, suggests one pharma exec.
AbbVie frames forecast-beating ex-US sales of Humira as a consequence of prices stabilising earlier than expected after the arrival of biosimilar competitors.
