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Boehringer Ingelheim abandons biosimilars outside the US

German drugmaker Boehringer Ingelheim will not commercialize its approved adalimumab product Cyltezo in Europe and is discontinuing all biosimilar development activities outside the US. Earlier this month, an article published in Bioprocess Insider considering the impending exit of Big Pharma from the biosimilars space brought a lot of attention from industry and investors. The piece drew on Merck KGaA’s abandonment of its biosimilars programs in 2017 as an example, and now fellow German Big Pharma firm Boehringer Ingelheim is contemplating…

WuXi building twelfth plant as biologics contracts ramp up

by Dan Stanton

With a portfolio approaching 200 products, CDMO WuXi Biologics has begun constructing a 1.6 million square-foot facility in Shanghai, China. Contract development and manufacturing organization (CDMO) WuXi Biologics is building what it calls a ‘Biologics Innovation Center’ in Fengxian, Shanghai. The 1.6 million square-foot facility will include biologics discovery and development laboratories, as well as GMP manufacturing, CEO Chris Chen told BioProcessing Insider. He added the labs will open in 2019, while the GMP plant will open its doors in…

EU gives conditional nod for Takeda Shire megamerger

by Dan Stanton

The European Commission (EC) has approved Takeda’s $62 billion acquisition on the proviso the firm divests Shire’s inflammatory bowel disease (IBD) candidate. In May, Japanese firm Takeda struck a deal to acquire Ireland-headquartered rare diseases biopharmaceutical company Shire for $62 billion (€54 billion). Six months on, the merger is one step closer after receiving approval under the EU Merger Regulation, on the condition of divesting Shire’s IBD candidate SHP647. “We can today approve the merger between Shire and Takeda, but…

Founding member Amgen turns back on Biosimilars Forum

by Dan Stanton

Amgen withdrew its membership from advocacy group The Biosimilars Forum in September after disagreeing on how best to support the US biosimilar market. Nonprofit organization The Biosimilars Forum was setup in 2015 “to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care… [by providing] evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars,” according to its mission statement. The founding 11…

Celgene investing in ‘vein to vein supply chain’ to support CAR-T biz

by Dan Stanton

Fresh from acquiring CAR-T firm Juno Therapeutics, Celgene is investing in patient treatment centers and building out its manufacturing capacity. In March, Celgene Corporation completed the $9 billion (€7.9 billion) acquisition of Juno Therapeutics, adding chimeric antigen receptor (CAR) T-cell technology and manufacturing capabilities, along with a pipeline of hematology and oncology therapies. Speaking at the Credit Suisse 27th Annual Healthcare Conference last week, CFO David Elkins said its numerous CAR-T collaborations – the firm has a co-development deal with…

Staffing shortage leaving blockbuster biologics undeveloped, says expert

by Dan Stanton

A shortage of bioprocess talent drives high salaries and hinders drug development, says BioPlan Associate’s Eric Langer. As biologics increasingly dominate pipelines, biomanufacturers look to traditional pharma to plug the staffing gaps. Speaking last month at the BIOLive event at CPhI Worldwide in Madrid, Eric Langer, president and managing partner at BioPlan Associates, said hiring is one of the biggest problems facing the biopharma industry. “It is painful [to the biopharma hiring managers] that 40% of the biopharma industry cannot hire…

Jazz on Erwinaze shortage: ‘We can’t sell what we don’t have’

by Dan Stanton

Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO. For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year. “Supply challenges continued to impact product availability in the third quarter,” CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further…

GE to use Wego to make single-use products in China, for China

by Dan Stanton

Wego Pharmaceutical Co. will manufacture single-use bioprocessing consumables on behalf of GE Healthcare from its facility in Weihai, China. The partnership with China’s Wego, financial details of which have not been divulged, will decrease product delivery times of GE Healthcare’s single-use bioprocessing products for Chinese biopharmaceutical companies, the firm says. “This collaboration helps local Chinese biomanufacturers focus on bringing much needed therapeutics to Chinese patients,” Olivier Loeillot, general manager of BioProcess at GE Healthcare Life Sciences, told BioProcess Insider. “Local…

Bye bye biosimilars: Big Pharma’s imminent exit in sight, says expert

by Dan Stanton

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term. Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate…

Novartis pulls US rituximab program citing FDA data demands

by Dan Stanton

Novartis subsidiary Sandoz has decided not to pursue a biosimilar of Roche’s Rituxan in the US after receiving a complete response letter from the FDA. In June 2017, biosimilar developer Sandoz received approval in Europe for Rixathon, a version of Rituxan (rituximab), which Roche markets as Mabthera in the region. But across the Atlantic, the Swiss biopharma has failed to replicate such regulatory success, and received a US Food and Drug Administration (FDA) complete response letter (CRL) in June this…