A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
A UK judge says a vexatious litigation strategy is staving off Humira biosimilars, but AbbVie is “playing by the rules and incurring the costs of doing so,” according to an IP lawyer.
The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
US FDA sticks with four-letter random suffix for biosimilar names
Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.
President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
Teva aiming to be major second and third wave biosimilars company
Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.
Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.
Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.
The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.
As the patent war over CRISPR gene editing technology continues, experts suggest a “one-stop” licensing alternative could help accelerate advances in new medicines.
Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.
A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.
The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19 target played a part.
Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.
A plan to attract advanced medicinal therapy manufacturing to the UK has emphasised the importance of the MHRA having a leading role in development of global regulatory standards.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.
US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
Biocon says it is well-positioned to up production of its Lantus biosimilar after the insulin glargine – co-developed with Mylan – was accepted for review in the EU.
Pfizer has said it will stop working on bococizumab and cease late phase trials of the monoclonal antibody (mAb) cholesterol buster being run by Ireland-based CRO, Icon.
Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.
Lonza has raised its 2016 guidance and predicted higher spending on manufacturing equipment after growth of its biopharma businesses in the third quarter.
Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.
Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?
