Global Markets

Sandoz roadmap aims to up biosimilar use 30% by 2030

The 12 goals within Sandoz’ Act4Biosimilars initiative hope to increase the global adoption of biosimilars by at least 30% in over 30 countries by 2030. Novartis’s Sandoz division is a pioneer in the biosimilars space, being the first company to receive approval of a biosimilar in the US through Zarxio, a version of Amgen’s Neupogen(filgrastim), in 2015. It has also been an advocate of these medicines, which have the potential to reduce the cost of medicine for patients and payors.…

Gilead: CAR-T still in infancy but the future is both auto and allo

Investment and innovation will continue to pour into autologous CAR-T therapies even as allogeneic products begin to impact the market, according to Gilead Sciences. Gilead Sciences is a pioneer in the cell therapy space, acquiring Kite Pharma in 2017 months ahead of the FDA approving Yescarta (axicabtagene ciloleucel), the second CAR-T therapy to achieve commercial success. Gilead won approval for a second autologous CAR-T, Tecartus (brexucabtagene autoleucel), in July 2020. Talking at the Bernstein Annual Strategic Decisions Conference last week,…

CEPI’s 100-day vaccine mission takes aim at future pandemics

Every single step of the vaccine process needs shortening says CEPI, which is developing a strategy to produce safe and effective vaccines against future threats in just 100 days. Face-to-face events are well underway, and BioProcess Insider headed to BPI Europe in Vienna, Austria where Anna Särnefält, CMC lead at the Coalition for Epidemic Preparedness Innovations (CEPI), said the key to responding to epidemics and pandemics is preparedness. The 100 Days Mission is a project that aims to  produce safe…

Bavarian Nordic to respond to monkeypox threat with vaccine supply

Bavarian Nordic will supply its smallpox vaccine Imvanex to at least two countries as cases of monkeypox surge in Europe and elsewhere. The surge of cases of monkeypox outside west and central Africa have alarmed health authorities over the past few weeks. While some commentators claim the outbreak is nothing to be too concerned about, some governments have looked to secure vaccinations in order to mitigate against a potential epidemic. There is no official vaccine for monkeypox in Europe, but…

Podcast: Opening the gates for women in biotech

There is no lack of talented women in the biotech space but the gates blocking their progression must be open for them to fully realize their potential, says consultant Nadine Ritter. Companies’ Diversity, Equality, and Inclusion (DEI) policies are too often just an exercise in box-checking, said Nadine Ritter, president and analytical advisor at Global Biotech Experts and long-time member of BioProcess International’s editorial board. “If it’s just virtual signaling on a website then I don’t care… show me the…

Keeping supply chains resilient in times of crisis

Robust risk management can offset supply chain problems that have been further aggravated by COVID-19, says Samsung Bioepis’ Thomas Newcomer. Since the start of the COVID-19 pandemic, the pharmaceutical industry has experienced many unprecedented situations. Disruptions to drug supply chains has become a primary concern across various markets. As much of the industry’s resources has been invested in pandemic response, the pharmaceutical industry has experienced an increase in supply chain or regulatory bottlenecks and in some cases drug shortages. This…

JSR launches services firm for biosimilar development

Newly formed business division Similis Bio will help companies improve efficiency and cost of biosimilar development, says JSR Life Sciences. According to JSR, Similis will provide biosimilar drug developers with solutions to drive development timelines and decrease associated costs. Additionally, Similis will supply partners with data to establish a biosimilar target as well as offering complete analytical and process development packages. The data packages include analytical procedures, product data, process knowledge, and CMC templates from a centralized model created to…

EureKING aims to create €1bn+ CDMO via EU SPAC

A group of biopharma pioneers have teamed up to raise $158 million to create a European bio-CDMO.   EureKING, a “blank-check” company — also known as a special-purpose acquisition company, or SPAC — claims to be the first European SPAC in healthcare devoted to biomanufacturing. The company aims to form a contract development manufacturing organization (CDMO) to be listed on Euronext Paris. To do so, eureKING is looking to raise €150 million ($158 million), which could be increased to €165…

Biogen and Aduhelm: ‘Manufacturing capabilities will align with demand’

With minimalized demand for the one-time touted blockbuster Aduhelm, Biogen could be left with 198,000 L of mammalian capacity to fill. Between its Swiss site in Solothurn and a plant in North Carolina, Biogen said last year it has a combined capacity of 198,000 L, capable of producing tens of millions of doses of Alzheimer’s drug Aduhelm (aducanumab). However, despite the US Food and Drug Administration (FDA) approving Aduhelm in June 2021, the commercial future of the monoclonal antibody (mAb)…

Maturing gene therapy pipelines driving Catalent growth and expansion

As pharma’s gene therapy pipeline matures, Catalent plans to invest more in the sector to meet high viral vector demand and advance growth. For the third quarter 2022, contract development manufacturing organization (CDMO) Catalent reported total revenues of $1.27 billion, an increase of 21% year-on-year. Catalent’s biologics segment came out as the top contributor to the CDMO’s financial performance, showcasing $698 million, representing net revenue growth of 30%over last year. Part of this success was due to “a notable increase”…