Three deals in the last week signal AbbVie’s strategy in immuno-oncology but are just the latest examples of Big Biopharma’s trend for clinical partnerships.
Triazamacrocyclic lipid complexes increase the efficiency of antibody-drug conjugates (ADCs) by delivering the payload right into the heart of a cancer cell, says BioCellChallenge.
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.
Eppendorf will tackle the challenges of scaling-up human induced pluripotent stem cells (hiPSCs) as part of a Horizon 2020 project to develop cell-based heart therapies.
Cell therapy firms must invest in engineering and learn from biopharma according to the US Government, which says high cost of regenerative treatments is slowing uptake.
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will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
Bristol-Myers Squibb has announced plans to set up a biomanufacturing process laboratory in collaboration with Ireland's National Institute of Bioprocessing Research and Training (NIBRT).
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
The partnership with recombinant protein development firm GTP Technologies will create an end-to-end manufacturing service, speeding up production of monoclonal antibodies and reducing costs, says Novasep.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
The changeover time between batches is significantly quicker using disposable equipment, says Avid Bioservices whose new biomanufacturing facility boasts several 1,000L single-use bioreactors.
Sanofi Pasteur, the vaccines division of Sanofi, has launched a vaccine research and development project targeting the prevention of Zika virus infection and disease.
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.
New facilities and a successful CMO tech transfer have helped turnaround the manufacturing of cell therapy product Ovasave, says TxCell after production was suspended last year.
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.
BioMarin expects commercial production of its recently approved orphan drug Vimizim (elosulfase alfa) to begin at a secondary facility in Ireland – acquired from Pfizer – mid-2017.
Scaling-up without expanding its manufacturing footprint was key in selecting Pall's Xpansion bioreactor, says UCL which is looking to create “the world’s largest therapeutic cell bank.”
Reliance on third-party technologies is leaving T-Cell drug developers vulnerable and has driven the larger players to invest in their own platforms, say experts.
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.
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.
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.
While data extrapolation is acceptable in approving US biosimilars across the same indications as its reference, the practice will not be applicable for the next generation of copycat biologics, a biotech expert says.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
Mucosis has been awarded a Wellcome Trust grant of €3.7m ($4m) to help develop a Respiratory Syncytial Virus (RSV) vaccine using its intranasal delivery platform.
Benepali has become the first biosimilar of Amgen’s Enbrel (etanercept) approved in Europe and marks the first regulatory success for Samsung Bioepis – a joint venture between Samsung Biologics and Biogen.
Pfizer has invested $46m in separate collaborations with four R&D companies specialising in developing ADCs, immuno-oncology candidates and gene-therapies.
The Cell Therapy Catapult (CTC) UK is in talks over gene and cell therapy partnerships similar to its latest deal with Cancer Research Technology and the University of Birmingham, says Chief Business Officer Matthew Durdy.
The coming year could see a spate of biosimilar approvals in the US following Sandoz’s success in 2015, according to an IP lawyer, but questions surrounding FDA’s requirements still remain.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.