The US Government is set to extend an anthrax vaccine supply contract, and Emergent Biosolutions believes its new commercial-scale facility coming online was a driving factor.
Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.
Octapharma has withdrawn one lot of its immune deficiency treatment Octagam after receiving reports of reports of allergic skin reactions in patients treated with the product.
Lonza plans to expand mammalian cell culture-based drug and viral manufacturing capacity after growth in both businesses helped it to record first quarter sales.
Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
Pfizer remains confident it will launch its biosimilar Inflectra in the US this year despite J&J assuring stakeholders it will defend Remicade’s IP beyond 2018.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Heat Biologics has announced several "necessary" but "incredibly difficult" cost cutting measures, including a workforce reduction of approximately 22%.
Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.
Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
Drug companies were a more important source of revenue for Lonza in 2015 than in previous years with four of its five biggest spending customers coming from the pharmaceutical sector.
Is the debate surrounding unique international nonproprietary names (INNs) for biosimilar products a delaying tactic driven by reference biologic makers? One market analyst believes so.
With more than 130 biotech and 20 pharmaceutical companies currently developing immuno-oncology (I/O) therapies, the global oncology market could reach $40bn by 2020, says Tufts.
It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio.
ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.
The larger the discount the more likely a US physician is to prescribe a biosimilar rather than an originator biologic according to the results of a survey.
JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.
Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.
Multiple sclerosis patients taking Tysabri (natalizumab) who are deemed to be at high risk for the lethal infection PML should have regular brain scans according to the EMA.
A US FDA advisory committee has voted overwhelmingly in favour of licensing Celltrion and Pfizer’s version of J&J’s Remicade, paving the way for the first US monoclonal antibody biosimilar.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
Biologics developers backed by Medicxi Ventures’ new €210m ($229m) fund will use Lonza for contract manufacturing under an existing deal with Index Ventures.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
Sandoz says gradual uptake of its biosimilar will eat away at Amgen’s filgastrim market share which stands at 76% four months after Zarxio’s entry in the US.
