Global Markets

J&J downgrades biosimilar threat as Q3 pulls in $10bn+ in pharma sales

J&J reported its sixth consecutive quarter with sales above $10 billion in its pharmaceutical division and has lowered its biosimilar headwind forecast to $2 billion. For the third quarter 2019, Johnson & Johnson (J&J) reported sales across all its units of $20.7 billion (€18.8 billion). Its pharmaceutical division pulled in roughly half of the total, $10.8 billion, up 5.1% on the same quarter last year. “This was our sixth consecutive quarter with sales above $10 billion,” Jennifer Taubert, EVP and…

Swiss CDMO Lonza testing the water in China… for now

With China set to become a major hub of biotech innovation, Lonza CEO Marc Funk says the CDMO will take a pragmatic approach to expanding its position from “timid actor” to major player in the region. When Marc Funk became CEO of Lonza in March 2019, he had two immediate objectives. The first was to carve out the contract development and manufacturing organization’s (CDMO) Specialty Ingredients segment (LSI) and the second was for the firm to be recognized more of…

Novartis supply-ready for approved wet AMD antibody fragment

Novartis says it is confident in its ability to supply Beovu (brolucizumab) after the single-chain antibody fragment received US FDA approval for treating wet AMD. The US Food and Drug Administration (FDA) this week approved Novartis’ anti-VEGF product Beovu for the treatment of patients with wet age-related macular degeneration (AMD) on a three-month dosing interval. A Novartis spokesperson did not divulge where the antibody fragment is made but told this publication the firm is confident in its ability to meet…

‘Unprecedented’ HPV vaccine demand to fuel more Merck capacity investments

Having recently invested over $1.6 billion in its network, Merck says it is committed to further expand the supply of its HPV vaccines as worldwide demand continues to spiral. Speaking at the at Morgan Stanley 17th Annual Global Healthcare Conference last month, Roger Perlmutter, EVP and president of Merck Research Laboratories, said human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 were the products that have the dominant near-term commercial potential for his firm. But a lack of manufacturing capacity at…

Biopharma continues to flex its Abs, survey shows

Results of KNect365’s Antibodies Emerging Tech Survey shows biopharma remains focused on monoclonal antibodies but acknowledges challenges persist, particularly in the discovery stage. There were over 200 respondents to the survey, with 81% of the organizations focusing on developing monoclonal antibody (MAb) therapeutics. This comes as no surprise, as the first Mab entered the market over 30 years ago in the form of Janssen-Cilag’s Orthoclone OKT3 (muromonab) and the modality has been deemed well-characterized by the US Food and Drug…

In the pipeline: Surge of cell and gene therapies likely in 2020

Over 20 cell and gene-based therapies are expected to be filed or to receive approval decisions over the next 18 months, according to the Alliance for Regenerative Medicine (ARM). Earlier this year, the US Food and Drug Administration (FDA) laid out its action plan to deal with the large upswing in the number of investigational new drug (IND) applications for cell and gene therapies it is receiving. “The FDA commissioner has anticipated that he thinks there will be between 10-20…

Novavax poised to step up to Executive Order with recombinant flu vaccine

President Trump has called for the modernization of influenza vaccine manufacturing. With its recombinant vaccine NanoFlu set to enter Phase III, Novavax says it offers the solution. Last week, the White House issued an ‘Executive Order [EO] on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health’ (reprinted below) aimed at addressing the “critical shortcomings” in the manufacture of such products. “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires…

Biosimilars: Low cost + high approval rate = good return for Amgen

Amgen says biosimilars represent an opportunity to get to market without the risk or cost of a novel biologic, so long as you have the capabilities. Within the biosimilar space, Amgen is curiously conflicted. It is one of the largest and most successful developers of such products, yet the firm is defending several of its novel blockbuster biologics from other biosimilar makers. In the US, where, Amgen has three approved products, launching two of them – Mvasi and Kanjiti, versions…

China laws settle CDMO status but leave regulator lacking capacity for oversight

New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…

Samsung BioLogics to establish US footprint with development labs

Korean CDMO Samsung BioLogics will open labs in either the Boston or San Francisco area early 2020 on the back of demand for its development services. In 2017, Samsung BioLogics added the ‘D’ to its contract development and manufacturing organization (CDMO) credentials by announcing plans to offer customers cell line and process development (PD) services on top of its well-established clinical and commercial production services. In the 18 months since launching these services, the South Korean firm has undertaken 33…