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.
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.
China’s food and drug administration recently gave the nod to the Beijing-based Sinovac to manufacture a vaccine to possibly prevent hand, foot and mouth disease (HFMD), a common contagious viral infection among young children.
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.
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.
The biosimilar market is rapidly growing after experiencing several significant developments in 2015 and is expected to be worth more than $32 billion by 2025.
The US FDA has approved Basaglar, a ‘follow-on’ version of Sanofi’s long-acting insulin Lantus developed in a joint venture between Eli Lilly and Boehringer Ingelheim.
CSL Behring will target growing Russian demand for protein-based therapies through a new Moscow office but says for now there are no plans for a local manufacturing site.
Samsung Bioepis will base its European operations in the UK at an entity set up to hold marketing authorizations for biosimilars it has filed for EMA review.
Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.
Korean regulators have approved a second Samsung Bioepis biosimilar, this time granting the JV rights to sell a version of J&J's Remicade (infliximab).
Preclinical CRO Biopta will add stem cell programming tech to its offering, expand in Japan and nearly double its workforce under new owner, Reprocell.
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) today revealed plans to remove market barriers to biosimilars and small molecule generics and create thousands of jobs.
Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.
Education is vital for biosimilar success in the US market, according to an industry advocacy group which is preparing to launch a programme for patients and healthcare providers.
