Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
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.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.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.
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.
PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
Arrowhead Pharmaceuticals Inc. has also laid off its Chief scientific officer David Lewis - as part of the 34 staff cull - after several trials using delivery vehicle Ex1 were stopped by the firm.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
Amgen confirms it is working on a version of Alexion's drug
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
The US FDA has updated its draft nonproprietary naming guidance allowing drugmakers to submit up to 10 suffixes for each new biologic and biosimilar product.
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.
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.
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.
Making the newly approved asthma drug Nucala (mepolizumab) involves facilities on both sides of the Atlantic according to GSK, which says it has no plan to outsource production.
Alexion says it is looking to bring more manufacturing capabilities in-house, despite its CMO partner Lonza recently setting up a dedicated suite at a site in New Hampshire.
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
FDA’s Janet Woodcook has defended delays in producing biosimilar interchangeability and labelling guidances, saying the scientific framework must first be ‘bulletproof.’
Review of Alexion’s enzyme replacement therapy Kanuma (sebelipase alfa) has been pushed back after the US FDA requested more Chemistry, Manufacturing and Controls (CMC) information.
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
Update - Wholesale cost of Zarxio will be 15% less than Amgen's Neupogen
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
Infectious disease vaccines for pregnant women will save countless infants, but companies need to clear practical and ethical concerns for licensure, says the US FDA.
The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), which manufactures products for clinical trials, has suspended operations due to the discovery of serious manufacturing problems and contamination by US FDA inspectors.
To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...
