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.
Celltrion has partnered with Nan Fung Group to create Vcell Healthcare, which will manufacture and commercialize three of Celltrion’s biosimilar products in China.
The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.
US FDA gives approval to Samsung Bioepis’ Humira biosimilar and Pfizer’s Rituxan biosimilar, as the number of such medicines gaining entry onto the US market steadily increases.
With US spending on biologics reaching $125.5bn in 2018, a new report looks at the level of savings that could potentially be made and contrasts the US with the European market.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
The major trend so far in 2019 is the willingness to deploy capital to expand services in the cell and gene therapy sector, and we outline the five most significant deals thus far.
Mundipharma partners with Prestige to commercialize and supply a biosimilar to Roche’s Herceptin, for patients with breast, gastric and gastroesophageal cancer.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
Celltrion plans to invest across its pharmaceutical business up to 2030, creating an estimated 110,000 new jobs in the process and launching 20 products.
Boehringer Ingelheim settles litigation with AbbVie over the possible introduction of its Humira biosimilar and agrees a license to market its competitor in 2023.
Allergan will expand its existing facilities in Ireland through an investment of €65m to produce new product formats for existing and investigational products.
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.
