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.
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
The news most interesting to our readers were those featuring collaborations, whether in the production of an Ebola vaccine, biosimilars entering new markets or creating new manufacturing modalities.
Shanghai Pharma and Biocad established a joint venture to commercialize the latter’s portfolio of biosimilars and biologic treatments for the Chinese market.
US FDA provides information to patients on biosimilars, emphasizing that the treatments provide the same benefits and are as safe as originator products.
Lonza’s facility in Singapore will provide Celltrion with the drug substance product to meet demand for the latter’s Remsima biosimilar in the European and US market.
iBio grants CC-Pharming exclusive license to commercialize rituximab in China, as well as a research license to bring its FastPharming technology to the country.
Asia’s largest integrated insulins facility, operated by a subsidiary of Biocon in Malaysia, receives GMP compliance certification from Ireland’s HPRA.
Dr Reddy’s Laboratories enters a $31m market with the launch of Versavo, a biosimilar of Roche’s Avastin in India, indicated for several types of cancer.
Revance Therapeutics says developing a Botox biosimilar is “challenging, but not impossible” in reply to AbbVie’s dismissal of the prospect of a copy of the blockbuster coming to market.
The US District Court for the District of New Jersey ruled in Amgen’s favor on the validity of the two patents on Enbrel and the methods for making it.
