Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.
Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
A tobacco plant-based platform could make monoclonal antibodies up to 90% cheaper than mammalian systems, says Axis Biotec which is building a pilot plant in Brazil.
Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.
An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.
Dr Reddy’s will expand its biosimilar manufacturing capacity in Hyderabad by 4,000L using GE Healthcare’s FlexFactory platform based on single-use technologies.
The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.
Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
Biocon's second fill/finish line at Bangalore site to come online later this year
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
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.
Teva aiming to be major second and third wave biosimilars company
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.
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.
Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.
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.
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.
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?
A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.
Long-awaited interchangeability guidance will strengthen the public’s confidence in biosimilars, but is likely to only affect 20% of all biological products, MedImmune and Biocon said at CPhI.
Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.