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

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The US FDA has published six draft guidance documents related to gene therapies.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…

US FDA Calls Biologic Makers to ‘INTERACT’ With New Program

by BPI Staff

The Agency has launched the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program to help sponsors plan development projects more effectively. The program is being introduced by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to allow potential sponsors to engage with Agency staff and obtain advice on a specific topics or issues critical to early product development. The discussions aim to advance product development by answering sponsors’ questions, removing roadblocks,…

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

by Dan Stanton

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

by Dan Stanton

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

by Dan Stanton

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…