Global Markets

Humira: AbbVie’s biosimilar erosion woes may be overstated

An analyst says general forecasts of biosimilar erosion for Humira (adalimumab) are too pessimistic as the size of the brand could still present upsides for AbbVie. AbbVie’s monoclonal antibody Humira continues to be the world’s top selling drug, despite biosimilar competition hitting sales outside of the US over the past few years. In 2020, global sales stood at $19.8 billion, $16.1 billion of which came from the US. As it stands, legal agreements between AbbVie and a host of biosimilar…

Chinese CDMOs eye advanced therapies and global markets

Univercells Technologies says traditional small molecule Chinese CDMOs are rapidly expanding into the cell and gene therapy space as it partners with viral vector producer VectorBuilder. The partnership will see Univercells Technologies – a bioprocess technology firm under KKR’s Gamma Biosciences umbrella – work with VectorBuilder’s manufacturing center in Guangzhou, China to develop and optimize platform processes for the production of custom viral vectors for both cell and gene therapies and vaccine applications. “Through this partnership, both parties will leverage…

$250m CAR-T startup ‘validates’ Intellia’s allogeneic and CRISPR platforms

Intellia Therapeutics, Blackstone, and Cellex have launched a CAR-T biotech aimed at developing chimeric antigen receptor (CAR) T-cell therapies. The new company will combine Intellia’s allogeneic cell platform and CRISPR cell engineering with Cellex subsidiary GEMoaB’s switchable universal CAR-T platforms – UniCAR and RevCAR – to develop a range of therapies against various cancers, including solid tumors. Blackstone Life Sciences has invested $250 million in the new venture, and the three companies – Blackstone, Intellia, and Cellex – will each…

Beyond the CDMO: Samsung Biologics reveals Big Pharma ambition

Having grown into one of the world’s largest bio-CDMOs over the past decade, Samsung Biologics says its next step is to become a top tier pharmaceutical company. Incheon, Korea-based contract development and manufacturing organization (CDMO) Samsung Biologics boasts three plants hosting a total of 364,000 L of mostly stainless-steel bioreactor capacity. Last year, the firm began construction on a fourth facility, housing an additional 256,000 liters of mammalian production capacity as well as fill/finish capabilities. “it’s going to be delivered…

COVID-19 driven CDMO investments to benefit wider sector

COVID-19 driven investments in vaccine production capacity will help relieve existing bottlenecks as the pandemic recedes, according to the authors of a new report. Demand for vaccine production capacity increased significantly last year as pharmaceutical industry efforts to develop effective jabs accelerated. The contract development and manufacturing organization (CDMO) sector’s response has been to invest in vaccine and vector production capacity, says Fiona Barry from GlobalData. “We’re seeing very high investment in vaccine-related contract manufacturing, by dedicated CDMOs and by…

Big Pharma collaborative trend to continue beyond COVID

Manufacturing collaboration between traditional rivals will be normal post-pandemic say GSK and Merck & Co., both of which are using their capacity to support fellow Big Pharma COVID-19 efforts. The biopharma space has traditionally been a highly competitive arena. Retaining intellectual property through secrecy, litigation, and other means is crucial to ensure maximum revenues from products developed at high-cost and high-risk. Just look at how the entrance of biosimilars have decimated certain company’s top line results. But a new era…

J&J: ‘We’re working with – but not dependent on – Emergent’

Talks are ongoing with troubled CDMO Emergent, but a robust production network means J&J is still on track to produce a billion doses of its COVID vaccine this year. In February, Johnson & Johnson (J&J) became the third firm to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a COVID-19 vaccine. The single shot offering received European authorization the following month. However, the vaccine has hit several snags. Questions around potential blood clots saw…

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…

Back to business? Demand for trials returning, says Icon

Icon says demand is recovering with bookings for its own services as well as those of soon-to-be acquired PRA continuing to climb in the second quarter. The Dublin, Ireland headquartered contract research organization (CRO) saw bookings increased 27% in the first quarter, versus the first three months of 2020, with book-to-bill ratio – roughly the value of new contracts divided by revenue – of 1.28. And the momentum has continued, according to CFO Brendan Brennan who spoke at Jefferies’ Healthcare…

Sepragen skids to help Serum Institute ramp up vaccine production

Sepragen has delivered two chromatography skids to the Serum Institute of India to help increase monthly production of COVID-19 vaccines from 40 million to 200 million doses. Bioprocess equipment manufacturer Sepragen Corporation recently shipped out two 125 liters/minute QuantaSep chromatography skids, with integrated inline buffer blending capabilities, to the Serum Institute, located in Pune, India. “These skids will allow the vaccine manufacturer to increase their production from 40 million doses per month to 200 million doses per month,” a Sepragen…