Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
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.
Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.
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.
The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
J&J cannot stop Inflectra arriving in the US in October but warns Pfizer of the risk of launching it while the patent surrounding Remicade’s manufacture remains unresolved.
An invalidated Remicade patent has paved the way for Pfizer to launch Inflectra in October, but legal battles with J&J are far from over says an IP lawyer.
StemCells Inc has merged with Israeli medical devices firm Microbot Medical three months after terminating a Phase II trial of its HuCNS-SC human neural stem cells.
Lucentis biosimilar developer Formycon saw its share price jump 16% days after Pfizer abandoned efforts to create a rival version of Roche's blockbuster eye drug.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
The US FDA has ordered Adaptimmune to halt a trial of its candidate liposarcoma therapy and asked for more information about how the treatment is made.
Highlighting indications approved through extrapolation and manufacturing information in drug labels are attempts to raise doubts over the safety of biosimilars, according to Sandoz.
Alexion has strengthened its Soliris (eculizumab) manufacturing IP and is developing a longer-acting C5 antibody ahead of potential biosimilar competition.
Epirus Biopharmaceuticals has filed for Chapter 7 bankruptcy protection, settled with licensee Livzon Mabpharm and handed its Remicade (infliximab) biosimilar to Reliance Life Sciences (RLS).
The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.
The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.
The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.
A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Amgen confirms it is working on a version of Alexion's drug
