Regulations Archives - Page 25 of 27 - BioProcess InternationalBioProcess International

Kyowa Hakko fermentation plant hit with FDA warning

Kyowa Hakko has received a US FDA warning letter citing GMP and data integrity issues at its amino acid production facility in Yamaguchi, Japan. The warning letter dated August 10 2018 came following an inspection of Kyowa Hakko Bio’s Hofu facility in September 2017 by the US Food and Drug Administration (FDA). Deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API) cited by the Agency included failures in Kyowa Hakko’s quality unit, along with a lack of…

US made biosimilars: Competitive advantage or marketing spin?

by Dan Stanton

Coherus says American healthcare providers and payers favor biosimilars made in the US over those made overseas. But an industry analyst has dismissed this saying location should not matter provided the facility is approved. Coherus’ second quarter 2018 contained several regulatory milestones relating to its candidate Udencya (pegfilgrastim-cbqv), a biosimilar candidate to Amgen’s Neulasta. A resubmission to the US Food and Drug Administration (FDA) was accepted in May, while in July Europe’s Committee for Medicinal Products for Human Use (CMPH)…

Jazz scales back Erwinaze push due to manufacturing disruptions

by Dan Stanton

To minimize impact on patients, Jazz Pharmaceuticals has reduced promotion of its cancer drug due to continued manufacturing issues at its CMO Porton Biopharma Limited (PBL). Erwinaze (asparaginase Erwinia chrysanthemi), an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, is used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. The product is made for Jazz Pharmaceuticals by Wiltshire, UK-based and UK-government backed biomanufacturer PBL. However, the US Food and Drug…

Alnylam’s success brings first RNAi therapeutic to US

by Dan Stanton

The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…

Celltrion receives FDA 483 with 8 ‘manageable and correctible’ observations

by Dan Stanton

Celltrion has received a US FDA Form 483 at its troubled biomanufacturing plant in Korea with eight observations not raised in a previous warning letter. In January, the US Food and Drug Administration (FDA) sent Korean drugmaker Celltrion a warning letter highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. An FDA reinspection last month has now resulted in a Form 483 with eight observations. The 483 itself, uploaded by the Agency, cites issues with Celltrion’s drug product and…

Plant Round-Up: Rubius Buys, WuXi Begins, Samsung Approved

by BPI Staff

Alexion sells its troubled plant to Rubius; Samsung BioLogics receives its first US license to make a Mab drug product; WuXi Biologics completes a GMP run at its Shanghai facility. Welcome to Insider’s facility round-up. Earlier this month, BioProcess Insider reported newly public Rubius Therapeutics had pledged to invest US$155 million (€133 million) to purchase, renovate and customize a facility in Smithfield, Rhode Island. At the time, the firm refused to divulge who they bought the facility from, but in…

FDA Greasing the Wheel for Biosimilar Adoption Through Action Plan

by Dan Stanton

The US FDA has published an action plan to promote and expedite biosimilar competition. Healthcare consultant Steven Lucio tells us “we are at a critical point in time in the biosimilar development landscape.” Last week, the US Food and Drug Administration (FDA) published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire for new biologics innovation. “By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest…

FDA Guidelines Show ‘Growing Maturity’ of Gene Therapy Space, Says Industry

by Dan Stanton

The US FDA has published six draft guidance documents related to gene therapies. The inclusion of manufacturing guidelines will help modernize the commercialization process to keep pace with the growth technology, say industry groups. Over the past 12 months, the US food and Drug Administration (FDA) has approved three separate gene therapy products: Novartis’ Kymriah (tisagenlecleucel), Gilead/Kite’s Yescarta (axicabtagene ciloleucel), and Spark Therapeutics’ Luxturna (voretigene neparvovec). And with a growing number of gene therapies moving through the clinic – there…

FDA Seeks Injunctions in Fight Against $2.4bn Unapproved Stem Cell Market

by Dan Stanton

Industry group International Society Cell and Gene Therapy (ISCT) has supported regulatory actions aimed at permanently closing two unapproved US stem cell clinics. The US Food and Drug Administration (FDA) is seeking a permanent injunction against Sunrise, Florida-based US Stem Cell Clinic LLC and Californian firm California Stem Cell Treatment Center Inc for marketing stem cell products without approval. The actions are the latest in a crackdown by the regulator on unproven cellular therapies (UCT) and complement a suite of…

Humira Biosimilars: Amgen Lawsuit ‘Stake in the Ground’ for Others

by Dan Stanton

Amgen will challenge AbbVie’s bestseller Humira in the US from 2023, following a lawsuit settled last year. Other adalimumab developers are likely to receive the same deal, an IP lawyer says. In September 2017, Amgen and AbbVie reached a settlement resolving all pending litigation in relation to the former’s Amjevita, a biosimilar version of the latter’s top-selling monoclonal antibody Humira (adalimumab). Amjevita became the third biosimilar to approved by the US Food and Drug Administration (FDA) in September 2016, but…